Surgical suturing device for repair of tricuspid regurgitation and methods thereof

ABSTRACT

A surgical suturing device is disclosed. The surgical suturing device may include a first or a second tissue gap, a first pair of needles configured to be movable across the first tissue gap, a second pair of needles configured to be movable across the second tissue gap, and a first suture having first and second ends. The surgical suturing device also includes a second suture having first and second ends and a needle actuator which selectively engages either: the first pair of needles to drive them through the first tissue gap and into communication with the first end of the first suture and the first end of the second suture, respectively; or the second pair of needles to drive them through the second tissue gap and into communication with the second end of the first suture and the second end of the second suture.

REFERENCE TO RELATED APPLICATIONS

This patent application claims priority to U.S. Provisional PatentApplication No. 62/730,521 filed Sep. 12, 2018 and entitled “SURGICALSUTURING DEVICE FOR REPAIR OF TRICUSPID REGURGITATION AND METHODSTHEREOF”. This patent application also claims priority to U.S.Provisional Patent Application No. 62/746,353 filed Oct. 16, 2018 andentitled “SURGICAL SUTURING DEVICE FOR REPAIR OF TRICUSPID REGURGITATIONAND METHODS THEREOF”. This patent application also claims priority toU.S. Provisional Patent Application No. 62/791,583 filed Jan. 11, 2019entitled “SURGICAL SUTURING DEVICE FOR REPAIR OF TRICUSPID REGURGITATIONAND METHODS THEREOF”. This patent application also claims priority toU.S. Provisional Patent Application No. 62/811,527 filed Feb. 27, 2019entitled “SURGICAL SUTURING DEVICE FOR REPAIR OF TRICUSPID REGURGITATIONAND METHODS THEREOF”. This patent application also claims priority toU.S. Provisional Patent Application 62/827,387 filed Apr. 1, 2019entitled “SURGICAL SUTURING DEVICE FOR REPAIR OF TRICUSPID REGURGITATIONAND METHODS THEREOF”. The 62/730,521, 62/746,353, 62/791,583,62/811,527, and 62/827,387 applications are hereby incorporated byreference in their entirety.

FIELD

The claimed invention relates to surgical devices, and more specificallyto a surgical suturing device useful in the correction of tricuspidregurgitation and methods thereof.

BACKGROUND

The availability of safe and effective therapy for tricuspid valve (TV)disease remains an area of significant unmet clinical need. Tricuspidregurgitation (TR) or the pathologic leakage of blood back into theright atrium during systole, quite common in cardiac patients withleft-sided valvular or myocardial disease, is estimated to affect >1.5million people in the United States, with a yearly incidence of about200,000 and >300,000 patients in the United States and Europe,respectively. Specific anatomic features from the TV complex might varyaccording to the causing mechanism (primary vs. secondary) andthroughout the progressive stages of ventricular remodeling in patientswith functional TR. TR is most often functional, primarily due toannular dilatation and leaflet tethering from right ventricularremodeling caused by left-sided heart disease, atrial fibrillation, orpulmonary hypertension. Primary TR accounts for ˜10% of cases of TR andcan be due to congenital (Ebstein's anomaly, prolapse) or acquireddiseases (rheumatic, endocarditis, carcinoid, endomyocardial fibrosis,intracardiac leads, or bioptome-related iatrogenic trauma). Today, TVdisease is often considered a marker for late-stage chronic heartfailure. TV is associated with a grim prognosis with most patientsreceiving lifetime medical therapy until intractable right heart failureand end-organ dysfunction appear.

Secondary TR has been divided into 3 stages for therapeutic purposes. Inthe early stage, initial dilation of the right ventricle leads totricuspid annular dilation without significant leaflet tethering.Annular-based systems should easily repair TR in these first stages. Inthe absence of long-term durability data for transcatheter TV therapyand on the basis of a surgical predicate, ring may be preferred oversuture annuloplasty when possible in order to reduce TR recurrence. Inthe second stage, progressive right ventricular and tricuspid annulardilation develop, impairing leaflet coaptation. The likelihood forsuccessful Transcatheter Tricuspid Valve Repair (TTVr) usingannuloplasty alone is less suitable in cases with progressive tetheringand tricuspid annular dilation. Finally, as the right ventriclecontinues to remodel, further leaflet tethering worsens, resulting in alack of coaptation and massive or torrential TR. When severe tetheringoccurs, any repair attempt could be considered futile.

FIG. 1A is a side cross-sectional view of a heart. The heart 10 is shownschematically with some of the relevant anatomical features in view. Thetricuspid valve 16 (TV) is a complex structure, with several anatomicpeculiarities rendering it unique. The TV apparatus, shown in FIG. 1A,normally has three leaflets, the septal leaflet 22, the posteriorleaflet 24, and the anterior leaflet 20, chordae tendineae 26, andusually three papillary muscles 28. Also shown are the general locationsof a superior vena cava 12 and an inferior vena cava 14.

As shown in FIG. 1B, the tricuspid annulus valve 16 is the largest offour heart valves, with very thin, fragile leaflets composing apotentially large regurgitant orifice area. The tricuspid valve 16 issurrounded by the tricuspid valve annulus 18 a saddle-shaped ellipsoidthat becomes planar and circular as it dilates primarily in theanterolateral free wall in patients with left-sided heart disease withsinus rhythm verses expanding mostly along the posterior border withless prominent leaflet tethering in patients with functional TRsecondary to chronic atrial fibrillation. Three leaflets, an anteriorleaflet 20, septal leaflet 22, and posterior leaflet 24 are also shownin FIG. 1B. The relative locations of a mitral valve 34 and mitralannulus 36, as well as an aortic valve 30 and aortic annulus 32, and apulmonary valve 38 and pulmonary annulus 40 are also indicated forreference. Four chief anatomic structures surround the TV and aretherefore at risk for interventions addressing TV disease: theconduction system (atrioventricular node and the right bundle of His)coursing the membranous septum at 3 to 5 mm from the anteroseptalcommissure, the right coronary artery (encircling the rightatrioventricular groove ˜5.5 mm from the septal and posterior portions,7 mm from the anterior portion), the non-coronary sinus of Valsalva, andthe coronary sinus ostium being an important landmark of theposteroseptal commissure. The TV apparatus poses additional challengingissues to overcome: lack of calcium, angulation in relation to thesuperior vena cava (SVC) and inferior vena cava (IVC), a trabeculatedand thin right ventricle hindering a transapical approach, or thepresence of pre-existing cardiac implantable electronic devices.

Traditional isolated TV surgery typically requires highly invasivesurgical access and cardio-pulmonary by-pass. Since this currentapproach continues to be associated with one of the highest risks ofmortality among all cardiac valve procedures in contemporary practice(operative mortality rates of 8.8% to 9.7%), it is rarely utilizedrelative to the large number of untreated TR patients (only 5,005isolated tricuspid procedures were performed in a large contemporaryU.S. nationwide registry over a 10-year period). Durability remains theAchilles heel of most surgical interventions addressing the TV. Manyfactors, such as right ventricular remodeling and dysfunction, tricuspidannular size progression, and pulmonary hypertension, may contribute tothe high rates of TR recurrence observed following surgical TRcorrection. Surgical experience has shown more sustained durability ofring annuloplasty compared with suture annuloplasty, as well as for TVreplacement over repair. However, concerns about increased perioperativemortality for TV replacement compared with repair in contemporaryseries—somewhat linked to selection bias of patients with largertricuspid annular dilation and more severe right ventriculardysfunction—have led to a trend over time toward TV repair rather thanreplacement.

Therefore, it would be desirable to have a reliable surgical suturingdevice for repair of tricuspid regurgitation as well as associatedmethods thereof. Ideally, such a device and method would be minimallyinvasive and not require aortic cross-clamp or cardio-pulmonary bypass(CPB) machine, thereby reducing the likelihood of CPB-related sideeffects. Faster and more reliable cardiac operations offer additionalbenefits, such as reduced surgical team fatigue and more efficient useof critical resources. Expediting cardiac surgery can also improvepatient outcomes.

SUMMARY

A surgical suturing device is disclosed. The surgical suturing deviceincludes a first tissue gap, a second tissue gap, a first pair ofneedles configured to be movable across the first tissue gap, a secondpair of needles configured to be movable across the second tissue gap,and a first suture having first and second ends. The surgical suturingdevice also includes a second suture having first and second ends and aneedle actuator which selectively engages either: the first pair ofneedles to drive them through the first tissue gap and intocommunication with the first end of the first suture and the first endof the second suture, respectively; or the second pair of needles todrive them through the second tissue gap and into communication with thesecond end of the first suture and the second end of the second suture.

Another surgical suturing device is disclosed. The surgical suturingdevice includes a first tissue gap, a second tissue gap, a first pair ofneedles configured to be movable across the first tissue gap, a secondpair of needles configured to be movable across the second tissue gap, afirst suture having first and second ends, a second suture having firstand second ends, a first needle actuator which engages the first pair ofneedles to drive them through the first tissue gap and intocommunication with the first end of the first suture and the first endof the second suture, respectively, and a second needle actuator whichengages the second pair of needles to drive them through the secondtissue gap and into communication with the second end of the firstsuture and the second end of the second suture.

A loading and retrieval apparatus is also disclosed. The loading andretrieval apparatus includes a pledget, a mechanical fastener, a snarepassing through the mechanical fastener and a proximal side of thepledget, forming at least one snare loop on a distal side of thepledget, and a tether loop passing through the pledget.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1B are cross-sectional views of a human heart.

FIG. 2 is a top-left-front perspective view of one embodiment of asurgical suturing device.

FIGS. 3A-3E are exploded views illustrating the assembly of a distal endof the surgical suturing device of FIG. 2.

FIGS. 4A-4H, 4J-4N, and 4P-4R are schematic illustrations of a surgicalmethod for repair of tricuspid regurgitation using the surgical suturingdevice of FIG. 2.

FIG. 5 is a schematic illustration of the surgical method for repair oftricuspid regurgitation showing an alternate embodiment of a surgicalsuturing device allowing for partial advancement of needles across thefirst and second tissue gaps.

FIGS. 6A-6C are top-left-front perspective views of another embodimentof a surgical suturing device.

FIG. 7 is an enlarged top-left-front perspective view of the distal tiplink of FIG. 6B.

FIGS. 8A-8C are top-left-front perspective views of another embodimentof a surgical suturing device.

FIG. 9 is a top view of the embodiment of the surgical suturing deviceof FIG. 8A.

FIG. 10 is a top view of the flexible shaft of the surgical suturingdevice of FIG. 8A.

FIGS. 11A-11F are cross-sectional views of flexible shaft vertebrasegments of FIG. 10.

FIGS. 12A-12B are perspective views of the unique vertebra segment ofFIG. 11B.

FIGS. 13A, 13B, 13C, 13D, 13E, and 13F are front, left side, right side,rear, top, and bottom elevational views, respectively of the uniquevertebra segment of FIGS. 12A-B.

FIGS. 14A-14B are perspective views of the unique vertebra segment ofFIG. 11C.

FIGS. 15A, 15B, 15C, 15D, 15E, and 15F are front, left side, right side,rear, top, and bottom elevational views, respectively of the uniquevertebra segment of FIGS. 14A-14B.

FIGS. 16A-16B are perspective views of the unique vertebra segment ofFIG. 11D.

FIGS. 17A, 17B, 17C, 17D, 17E, and 17F are front, left side, right side,rear, top, and bottom elevational views, respectively of the uniquevertebra segment of FIGS. 16A-16B.

FIGS. 18A-18B are perspective views of the unique vertebra segment ofFIG. 11E.

FIGS. 19A, 19B, 19C, 19D, 19E, and 19F are front, left side, right side,rear, top, and bottom elevational views, respectively of the uniquevertebra segment of FIGS. 18A-18B.

FIGS. 20A-20B are perspective views of the unique vertebra segment ofFIG. 11F.

FIGS. 21A, 21B, 21C, 21D, 21E, and 21F are front, left side, right side,rear, top, and bottom elevational views, respectively of the uniquevertebra segment of FIGS. 20A-20B.

FIG. 22 is an enlarged top view of another embodiment of a proximal endof a surgical suturing device.

FIG. 23A-23B are side views of an embodiment of an articulation controllever of the surgical suturing device of FIG. 22 shown in an engagedposition and disengaged position, respectively.

FIG. 24A is a top-left-front perspective view of another embodiment of asurgical suturing device.

FIGS. 24B-24C are enlarged top-left-front and top-left-rear perspectiveviews, respectively, of portions of the surgical suturing device of FIG.24A.

FIG. 25 is a top-left front perspective view of an embodiment of aloading and retrieval apparatus.

FIG. 26A-26D are top-left-front perspective views of various aspects ofanother embodiment of a loading and retrieval apparatus.

FIG. 27 is a top-right-front perspective view of another embodiment of asurgical suturing device.

FIGS. 28A-28B are top partial cross-sectional schematic views of aretracting telescope of the surgical suturing device of FIG. 27.

FIG. 29 is a top-right-front perspective view of another embodiment of asurgical suturing device.

FIGS. 30A-30H, 30J-30N, 30P-30Z, 30AA-30AH, 30AJ-30AN, and 30AP areexploded views illustrating the assembly of the surgical suturing deviceof FIG. 29.

FIG. 31A is a top-left-rear perspective view of a portion of thesurgical suturing device of FIG. 29.

FIGS. 31B-31C are top-left-front perspective views of the distal tip ofthe surgical suturing instrument of FIG. 29.

FIGS. 32A-32B are perspective views of the distal tip of the surgicalsuturing device of FIG. 29.

FIGS. 33A, 33B, 33C, 33D, 33E, and 33F are front, left side, right side,rear, top, and bottom elevational views, respectively of the distal tipof FIGS. 32A-32B.

FIGS. 34A-34D are a series of partial top views of the surgical suturingdevice of FIG. 29 illustrating the operational principles of the distaltip articulation.

FIGS. 35A-35G are side partial cross-sectional views of the surgicalsuturing device of FIG. 29 illustrating the operation principles of theneedle drivers and retracting telescope.

FIG. 36 is a top view of the flexible shaft portion of the surgicalsuturing device of FIG. 29.

FIGS. 37A-37F are cross-sectional views of flexible shaft vertebrasegments of FIG. 36.

FIGS. 38A-38B are perspective views of the unique vertebra segment ofFIG. 37A.

FIGS. 39A, 39B, 39C, 39D, 39E, and 39F are front, left side, right side,rear, top, and bottom elevational views, respectively of the uniquevertebra segment of FIGS. 38A-38B.

FIGS. 40A-40B are perspective views of the unique vertebra segment ofFIG. 37B.

FIGS. 41A, 41B, 41C, 41D, 41E, and 41F are front, left side, right side,rear, top, and bottom elevational views, respectively of the uniquevertebra segment of FIGS. 40A-40B.

FIGS. 42A-42B are perspective views of the unique vertebra segment ofFIG. 37C.

FIGS. 43A, 43B, 43C, 43D, 43E, and 43F are front, left side, right side,rear, top, and bottom elevational views, respectively of the uniquevertebra segment of FIGS. 42A-42B.

FIGS. 44A-44B are perspective views of the unique vertebra segment ofFIG. 37D.

FIGS. 45A, 45B, 45C, 45D, 45E, and 45F are front, left side, right side,rear, top, and bottom elevational views, respectively of the uniquevertebra segment of FIGS. 44A and 44B.

FIGS. 46A-46B are perspective views of the unique vertebra segment ofFIG. 37E.

FIGS. 47A, 47B, 47C, 47D, 47E, and 47F are front, left side, right side,rear, top, and bottom elevational views, respectively of the uniquevertebra segment of FIGS. 46A and 46B.

FIGS. 48A-48B are perspective views of the unique vertebra segment ofFIG. 37F.

FIGS. 49A, 49B, 49C, 49D, 49E, and 49F are front, left side, right side,rear, top, and bottom elevational views, respectively of the uniquevertebra segment of FIGS. 48A and 48B.

FIG. 50 is a top-right-front perspective view of another embodiment of asurgical suturing device.

FIGS. 51A-51B are perspective views of a distal tip of the surgicalsuturing device of FIG. 50.

FIGS. 52A, 52B, 52C, 52D, 52E, and 52F are front, left side, right side,rear, top, and bottom elevational views, respectively, of the distal tipof FIGS. 51A-51B.

FIG. 53 is a left-front perspective view of the distal tip of FIG.51A-51B.

FIG. 54 is a top-right-front perspective view of an embodiment of amechanical fastener knotting device having two shafts or barrels.

FIGS. 55A and 55B are top and bottom perspective views, respectively, ofa cannula for use in combination with the surgical suturing device ofFIG. 50.

FIG. 56 is a top view of the flexible shaft portion of the surgicalsuturing device of FIG. 50, detailing a number of unique vertebraesegments or links.

FIGS. 57A-57C are cross-sectional views of flexible shaft vertebrasegments of FIG. 56.

FIGS. 58A-58B are perspective views of the unique vertebra segment ofFIG. 57A.

FIGS. 59A, 59B, 59C, 59D, 59E, and 59F are front, left side, right side,rear, top, and bottom elevational views, respectively of the uniquevertebra segment of FIGS. 58A-58B.

FIGS. 60A-60B are perspective views of the unique vertebra segment ofFIG. 58B.

FIGS. 61A, 61B, 61C, 61D, 61E, and 61F are front, left side, right side,rear, top, and bottom elevational views, respectively of the uniquevertebra segment of FIGS. 60A and 60B.

FIGS. 62A-62B are perspective views of the unique vertebra segment ofFIG. 58C.

FIGS. 63A, 63B, 63C, 63D, 63E, and 63F are front, left side, right side,rear, top, and bottom elevational views, respectively of the uniquevertebra segment of FIGS. 62A and 62B.

FIG. 64 is a top-right-front perspective view of another embodiment of asurgical suturing device.

FIG. 65 is a top-right-front perspective view of an embodiment of amechanical fastener knotting device having three shafts or barrels.

FIG. 66A is a top-right-front perspective view of a distal tip of thesurgical suturing device of FIG. 64.

FIG. 66B is a front view of the distal tip of FIG. 66A.

FIGS. 67A-67H, and 67J-67L are a series of schematic illustrations of asurgical method for repair of tricuspid regurgitation using the surgicalsuturing device of FIG. 64.

FIGS. 68A-68B are top-left-front perspective views of internal portionsof an embodiment of a surgical suturing device highlighting thearrangement of a set of needles.

FIG. 69 is a top-left-front perspective view of internal portions of theembodiment of the surgical suturing device of FIGS. 68A and 68B furtherhighlighting the arrangement of a set of needles.

FIG. 70 is an enlarged cross-sectional side view of a segment of theinternal portions of a surgical suturing device shown in FIG. 69.

FIG. 71 is a top-right-front perspective view of another embodiment of adistal tip for a surgical suturing device.

It will be appreciated that for purposes of clarity and where deemedappropriate, reference numerals have been repeated in the figures toindicate corresponding features, and that the various elements in thedrawings have not necessarily been drawn to scale in order to bettershow the features.

DETAILED DESCRIPTION

FIG. 2 illustrates one embodiment of a surgical suturing device 50. Thesurgical suturing device 50 has a handle 54 and a lever 56 which ispivotable with respect to the handle 54. The device also has a selectionswitch 58. Extending from the handle housing 52 is a flexible shaft 60which terminates in a distal tip 62. The distal tip 62 defines a firsttissue gap 64 and a second tissue gap 66, which in this embodiment aresymmetrical and facing opposite directions.

FIGS. 3A-3E are exploded views illustrating assembly of the distal endof the device. As shown in FIG. 3A, a first pair of needles 72 arecoupled to a first needle holder 70. A first needle drive wire 68 isalso coupled to the first needle holder 70. A second pair of needles 78are coupled to a second needle holder 76. A second needle drive wire 74is also coupled to the second needle holder 76. Although not shown inthese views, the first and second needle drive wires 68, 74 will passthrough the flexible shaft 60 and will be coupled to the selectionswitch 58. Those skilled in the art are familiar with mechanisms whichwill enable a squeezing of the device lever 56 to move the first pair ofneedles 72 when it is in a first selection position, while also enablinga squeezing of the device lever 56 to move the second pair of needles 74when the selection switch 58 is in a second position. Having only twoneedle drive wires leaves open the possibility of locating the needledrive wires along a single line on which the flexible shaft 60 may moreeasily bend. In other embodiments, the two needles which make up thefirst pair of needles 72 and the two needles which make up the secondpair of needles 78 may be long enough to pass all the way back throughthe flexible shaft 60 to the handle housing 52 where they can be coupledto the selection switch 58 more proximal to the user.

As shown in FIG. 3B, the device has a first suture 86 which has its ownfirst and second ends 88, 90. A first ferrule 92 is coupled to the firstend of the first suture 86, while a second ferrule 94 is coupled to thesecond end of the first suture 86. The distal tip 62 defines a firstferrule holder 80 adjacent to the first tissue gap 64. The distal tip 62also defines a second ferrule holder 82 adjacent to the second tissuegap 66. The first ferrule 92 is placed within the first ferrule holder80, while the second ferrule 94 is placed within the second ferruleholder 82. At least a portion of the middle of the first suture 86 isplaced into a first suture passage 84 of the distal tip 62. The firstsuture 86 will be long enough so that the suture middle or approximatemiddle can reach all the way to the housing handle 52, or at leastbeyond the flexible shaft 60. FIG. 3C shows the first suture 86 and itsferrules 92, 94 installed in the distal tip 62.

As shown in FIG. 3D, the device has a second suture 104 which has itsown first and second ends 106, 108. A third ferrule 110 is coupled tothe first end of the second suture 106, while a fourth ferrule 112 iscoupled to the second end of the second suture 108. The distal tip 62defines a third ferrule holder 100 adjacent to the first tissue gap 64.The distal tip 62 also defines a fourth ferrule holder 102 adjacent tothe second tissue gap 66. The third ferrule 110 is placed within thethird ferrule holder 100, while the fourth ferrule 112 is placed withinthe fourth ferrule holder 102. At least a portion of the middle of thesecond suture 104 is placed into a second suture passage 98 of thedistal tip 62. The second suture 104 will be long enough so that thesuture middle or approximate middle can reach all the way to the housinghandle 54, or at least beyond the flexible shaft 60. FIG. 3E shows thefirst and second sutures 86, 104 and their ferrules installed in thedistal tip 62. FIG. 3E also shows a guidewire channel 114 which isformed through the distal tip 62. The guidewire channel 114 continuesthrough the end of the flexible shaft 60, and it allows a guidewire tobe inserted therein so that the device can be passed over a guidewire toa surgical location.

Referring to FIG. 3B again, the first and second pairs of needles areinserted into the distal tip 62 in alignment with the ferrules. Thefirst ferrule holder 80 and third ferrule holder 100 are configured toalign the first ferrule 92 and the third ferrule 110 in alignment with atravel path of the first pair of needles 72 when traversing the firsttissue gap 64, respectively. The second ferrule holder 82 and fourthferrule holder 102 are configured to align the second ferrule 94 and thefourth ferrule 112 in alignment with a travel path of the second pair ofneedles 74 when traversing the second tissue gap 66, respectively.

FIGS. 4A-4H, 4J-4N, and 4P-4R schematically illustrate a surgical methodfor repair of tricuspid regurgitation using the surgical suturing deviceof FIG. 2. FIG. 4A illustrates an example starting surgical situation,where the surgeon locates an incision site 118 on a patient's neck 116in a location which will allow access to the inner jugular vein 120. Theinner jugular vein 120 joins the superior vena cava 122 which then leadsto the right atrium 130 of the heart 124. The inferior vena cava 122also leads to the right atrium 130 of the heart 124 from the patient'slower body. The tricuspid valve 126 is located between the right atrium130 and the right ventricle 128.

As schematically illustrated in FIG. 4B, a cannula 134 is placed intothe inner jugular vein 120, and a guidewire 136 is advanced down theinner jugular vein 120, through the superior vena cava 122, and into theright atrium 130 until it is positioned within the tricuspid valve 126.These steps, like all the steps of this procedure, may be performedwhile the patient is under conscious sedation and while the heart isstill beating. This is advantageous because it avoids aortic crossclamping, cardiopulmonary bypass, and the complications associatedtherewith.

As shown in FIG. 4C, the surgical suturing device 50 has been advancedthrough the cannula 134 and over the guidewire 136 so that the distaltip 62 is located within the tricuspid valve 126. The surgical suturingdevice 50 may have steering controls to help guide the flexible shaft60. The flexible shaft 60 may include a series of linked vertebrae aswell as one or more articulating links which can be angled as desired.FIG. 4D is an enlarged view of the heart 124 from FIG. 4C. It can beseen that the tissue gaps 64, 66 in the distal tip 62 are generallyaligned with the tricuspid annulus 140.

As shown in FIG. 4E, the distal tip 62 is further positioned against oneside of the tricuspid valve 126 so that one side of the annulus iswithin the first tissue gap 64. As shown in the enlarged view of FIG.4F, the first pair of needles 72 are advanced (by squeezing the leverwhich is not shown) through the tissue in the tissue gap 64 and intocontact with the first and third ferrules 92, 110. For simplicity, thesutures are not shown in this view. The needles couple with theirrespective ferrules, and then the needles are retracted (by releasingthe lever which is not shown) back through the tissue in the tissue gap,as shown in FIG. 4G, pulling the first end of the first suture 86 andthe first end of the second suture 106 back through the tissue as well.

As shown in FIG. 4H, the distal tip 62 is now positioned against theopposite side of the annulus so that a second annulus location is placedwithin the second tissue gap 66. The stitches made from the first end ofthe first suture 86 and the first end of the second suture 106 at thefirst annulus location can clearly be seen in this view. Note that thereis no FIG. 4I, as this looks confusingly like the number 41. The userswitches the selector switch 58 so that the second pair of needles 78may be actuated, and as shown in the enlarged view of FIG. 4J, thesecond pair of needles 78 are advanced (by squeezing the lever which isnot shown) through the tissue in the second tissue gap 66 and intocontact with the second and fourth ferrules 94, 112. The needles couplewith their respective ferrules, and then the needles are retracted (byreleasing the lever which is not shown) back through the tissue in thesecond tissue gap 66, as shown in FIG. 4K, pulling the second end of thefirst suture 86 and the second end of the second suture 108 back throughthe tissue as well. Thus, the selector switch 58 can be switched toselectively couple either the first pair of needles 72 or the secondpair of needles 78.

As shown in FIG. 4L, the device is carefully removed from the patient asthe sutures are allowed to payout from the device. Once the device isoutside of the patient, the ends of the first and second sutures may becut from the device, leaving the ferrules behind in the suturing device,and the suturing device may be set aside. As illustrated in FIG. 4M, afirst pledget 146 may be placed over the first end of the first suture86 and the first end of the second suture 106 and advanced down to thefirst location on the tricuspid annulus 140. Similarly, as secondpledget 148 may be placed over the second end of the first suture 86 andthe second end of the second suture 106 and advanced down to the secondlocation on the tricuspid annulus 140.

As illustrated in FIG. 4N, a mechanical fastener 150, such as theCOR-KNOT® titanium fastener available from LSI Solutions, Inc., Victor,N.Y. may be used to secure the first and second sutures 86, 104 againstthe first and second pledgets 146, 148 at the second annulus location.The excess second end of the first suture 86 and excess second end ofthe second suture 106 are also trimmed away. Note that there is not aFIG. 4O, since this looks confusingly like the number 40.

As illustrated in FIG. 4P, the first ends of the first and secondsutures 88, 106 may be threaded through a mechanical fastening device152, like a COR-KNOT® Device. The mechanical fastening device 152 holdsa mechanical fastener 150, such as a titanium fastener, which can beplaced against the first pledget 146 at the first annulus location.Before the mechanical fastener 150 is applied, however, the first andsecond sutures 86, 104 are tensioned, drawing the opposite ends of thetricuspid annulus 140 together. When the opposite sides of the tricuspidannulus 140 are touching each other, the second mechanical fastener 154is applied, the excess suture ends are trimmed, and the result is thecreation of a double orifice 156 in the tricuspid valve 126 as shown inFIG. 4Q and the enlarged view of FIG. 4R. The double orifice 156 has theadvantage of enabling the tricuspid leaflets to coapt properly, therebyrepairing the tricuspid valve to prevent tricuspid regurgitation.

Looking back at FIG. 4M, the tricuspid chordae 144, which tether thetricuspid valve leaflets to the right ventricle, can be seen. When thesurgical suturing device 50 is first being positioned on the guidewire136 within the tricuspid valve 126, some embodiments may allow for theneedles to be partially advanced across the first and second tissue gaps64, 66 as shown in FIG. 5. In this position, the needles are not farenough forward to engage the ferrules, however, the needles may help toblock chordae from entering and being snagged by the first and secondtissue gaps 64, 66 of the distal tip 62. The needles in this positioncan be said to be in a guard position. When the user is ready to placetissue within one of the gaps, the corresponding needles can bewithdrawn to a retracted position and the procedure may go ahead asdetailed in the above embodiment.

FIG. 6A illustrates another embodiment of a surgical suturing device.This embodiment is similar to the previous embodiment but has somedifferences. For example, the device of FIG. 6A includes a guidewire tip168 over the distal tip 164 at the end of the shaft 162. The guidewiretip 168 has an opening in its side. The distal tip 164 can be seenthrough this opening. In the view of FIG. 6A, the distal tip 164 is in aretracted position. As shown in FIG. 6B, however, the distal tiparticulating link 170 and an adjacent articulation link 172 may be movedto an advanced position outside of the guidewire tip 168. Othervertebrae, not shown here, may continue through the shaft 162, allowingthe articulation links to remain coupled to the shaft 162, but allowingfor the shaft 162 to be flexible.

The device of FIGS. 6A and 6B will allow the guidewire tip 168 to passover a guidewire 136. The guidewire 136 would not pass through thedistal articulating tip, but it would still pass through the deviceshaft 162. This would allow the guidewire 136 to be kept out of theheart 124. Instead, the guidewire 136 could be advanced past the rightatrium 130 and down into the inferior vena cava 132. The guidewire tip168 would also stay out of the right atrium 130, however, the distal tip164 link and the articulating link 172 would be able to reach into theright atrium 130 to the tricuspid valve 126 to place the suture stitchessimilarly to what has been described above. FIG. 6C illustrates thesurgical suturing device of FIG. 6A, having an additional IVC guide tip174, which is a soft, flexible proboscis or monorail over the distal tip164 of the surgical suturing device 160, which is configured to assistin insertion and positioning of the distal tip 164 of the surgicalsuturing device 160 within the patient. The proboscis is configured toreduce trauma during this procedural step.

FIG. 7 is an enlarged top-left-front perspective view of the distal tip164 link from FIG. 6B. In this embodiment, the first and second tissuegaps 176,178 face in opposite directions, but they are staggered insteadof symmetrical. This type of embodiment allows for a smaller diameter ofthe distal tip link 170.

FIG. 8A illustrates another embodiment of a surgical suturing device180. In this embodiment, a control panel is located between the shaft182 and the handle housing 184. Two articulation control levers 192 arecoupled to the two articulation links 192 at the distal end. In theposition shown, the distal tip 164 is in a retracted position. Steeringcables (not visible in this view) connect the control levers to thedistal links so that the links may be moved. A tension cable may beprovided within the device shaft 182 and coupled to a locking control188. To enable movement, the tension cable is untensioned by releasingthe locking control 188. Once a desired position for the distal tip 164is established, the tension cable may be tensioned by locking thelocking control 188.

A suture viewing window 190 may also be provided in the control panel186. As described above, the middles of the first and second sutures 86,104 are fed up through the device shaft 182 when the device isassembled. A portion of this middle suture may be placed to be visiblewithin the suture viewing window 190 so that successful stitching may beverified through movement of the suture middle portions after squeezingand releasing the device lever 56. When needles successfully passthrough tissue, engage a ferrule, and pull the ferrule back through thetissue, the attached suture is also pulled through the tissue. As thesuture moves through the tissue, its middle will also move within thesuture viewing window 190, providing valuable feedback to the surgeon.Suture viewing windows 190 such as this may be continuous oralternatively in separate locations on the control panel 186 or housingdepending on the number of sutures required to be loaded in the deviceor instrument.

FIG. 8B is an enlarged perspective view of an embodiment of a proximalend of a surgical suturing device 180, focusing on the control panel186. In this view, a proximal articulation control lever 194 and adistal articulation control lever 192 positioned atop the control panelsurface 196, are both shown in an articulated position. The proximalarticulation control lever 194 is configured to flex or articulate twoarticulation joints 208, 214 in the flexible shaft 182, and the distalarticulation control lever 192 is configured to articulate a secondarticulation joint 214 in the flexible shaft 182. These articulationjoints 208, 214 are further discussed in regard to FIG. 8C. Each of thearticulation control levers 192, 194 are paired with several positionalkeyways, located on the control panel surface 196, which are configuredto receive a key (not visible here) attached to the underside of thearticulation control lever 192, 194. The keys will hold eacharticulation control lever 192, 194 in a specific keyway position untilmoved by the operator. This is not shown in this view but discussedlater in regard to FIGS. 23A and 23B. The control panel 186 also has alocking control 188, which is shown in a fully articulated position andis configured to travel within a locking channel 198. This function isnot fully shown in this view but is discussed later in regard to analternate embodiment described in regard to FIG. 22.

FIG. 8C is an enlarged perspective view of the distal end of anembodiment of a surgical suturing device 180, focusing on the distal tip220 and distal articulation joints 208, 214. This illustrates twovertebrae 206, 207 segments or links at the proximal end of the flexibleshaft 204, connected sequentially to a first middle link, a secondmiddle link 212, a distal jaw link 216, and a distal tip 220 having afirst tissue gap 222 and a second tissue gap 224. An IVC (inferior venacava) guide tip 226 is also attached to the distal jaw link 216 and islocated at the distal end of the flexible shaft 182 of the surgicalsuturing device 180. The IVC guide tip 226 has a guide wire channel 228at its distal end. In other embodiments, there may be a soft, flexibleproboscis or monorail on the end of the IVC guide tip 226 configured toassist in insertion and positioning of the distal tip 220 of thesurgical suturing device 180 within the patient. The proboscis isconfigured to reduce trauma during this procedural step. Referring backto FIG. 8B, the proximal articulation control lever 194, whenarticulated, will flex or articulate the first two articulation joints208, 214 in the flexible shaft 182 which are located between the lastvertebrae 207 and the first middle link, and between the first middlelink and the second middle link 212. The distal articulation controllever 192 will flex or articulate the second articulation joint 214located between the second middle link 212 and the distal jaw link 216.As described previously, the amount of flex or articulation selectedwith each of the articulation control levers 192, 194 will be fixed inplace by the engagement of the positional keyways 200, 202 located onthe control panel surface 196 and the keys located on the proximalarticulation control lever 194 and the distal articulation control lever192. As the first two articulation joints 208, 214 and the secondarticulation joints 214 are flexed or articulated in order to make therequired tissue bites as previously described, the IVC guide tip 226remains parallel and aligned with the original axis of the flexibleshaft 182.

FIG. 9 is a top view of the embodiment of the surgical suturing device180 of FIG. 8A. The distal tip 220, flexible shaft 182, control panel186, housing handle 184 as previously described are shown in this view.On the control panel 186 are the suture viewing window 190 with twovisible sutures 232, 234, the distal articulation control lever 192 in anon-actuated position, the proximal articulation control lever 194 in apartially articulated position, and the locking control 188 in apartially locked position.

FIG. 10 is a top view of the flexible shaft of the surgical suturingdevice 180 of FIG. 8A, detailing a number of unique vertebrae segmentsor links, the cross-sections of which are shown in greater detail inFIGS. 11A-F. These vertebrae segments 206, 207, 210, 212, 216, whenconnected, comprise the flexible shaft 182 of the surgical suturingdevice 180 of the present disclosure. Illustrated in FIG. 10 is a firstvertebrae 236 indicated by cross-sectional marker 11A, several vertebraesegments 206, 207, 210, 212, 216 indicated by cross-sectional markers11B, 11C, and 11D, 11E, and 11F. The first vertebrae 236, indicated bycross-sectional marker 11A, includes a linking end 238 to fixedly attachthe flexible shaft 182 to the control panel 186 section of the surgicalsuturing device 180. The cross-sectional features of these vertebrae arefurther discussed in regard to FIGS. 11A, 11B, 11C, 11D, 11E, and 11F.The cross-sectional features shown in this embodiment of the surgicalsuturing device 180 are one arrangement, and it should be noted thatother arrangements or configurations may be useful or effective inmaintaining and articulating the various control and locking cables,sutures, guide wire, and needle pairs along the internal path of aflexible shaft 182 may be known to those skilled in the art.

FIG. 11A is a cross section of the vertebra segment of FIG. 10. Theinner structure of the first vertebra 236 possesses several featuresrelated to cable pathway management throughout the length of theflexible shaft 182. The vertebra segment 236 defines two first needlechannels 254 which are configured to guide the first needle pair alongthe flexible shaft 182. The vertebra segment 236 also defines a firstsuture pair path 252, surrounded by two distal articulation cablechannels 240, which are configured to guide the first suture pair andthe distal articulation cables from the distal articulation lever 192along the flexible shaft 182 to the distal jaw articulation joint. Thedistal articulation cables, not shown in this view, include a pullingarticulation cable and a return articulation cable. The vertebra segment236 further defines a central locking cable channel 242 configured toguide the locking cable from the locking control mechanism throughoutthe flexible shaft 182. The vertebra segment 236 further defines aguidewire channel 250 which carries the guidewire along the flexibleshaft 182, and finally a second suture pair path 248, proximalarticulation cable channels 244, and second needle channels 246. Thesechannels are configured to guide the second suture pair, the proximalarticulation cables, and the second needle pair along the flexible shaft182.

FIG. 11B is a cross section of the vertebra segment 206 of FIG. 10. Theinner structure of this vertebra possesses several features related tocable pathway management throughout the length of the flexible shaft182. The inner structure is identical to the vertebra 236 illustrated inFIG. 11A, however, the vertebra segment 206 of FIG. 11B does not have alinking end as in the vertebra segment 236 of FIG. 11A.

FIG. 11C is a cross section of the vertebra segment 207 of FIG. 10. Theinner structure of this vertebra possesses several features related tocable pathway management throughout the length of the flexible shaft182. The inner structure is similar to the vertebrae illustrated inFIGS. 11A-11B, except that the guidewire channel 284 terminates at thisvertebra segment 207 in the flexible shaft 182, where the guidewirepasses through to the guidewire channel 250 in the IVC guide.

FIG. 11D is a cross section of the vertebra segment 210 of FIG. 10. Theouter structure of this vertebra segment 210 is flat on one side toaccommodate the IVC guide shown in FIG. 10. The inner structure of thisvertebra possesses several features related to cable pathway managementthroughout the length of the flexible shaft 182. The inner structure issimilar to the vertebrae illustrated in FIGS. 11A-11C, but the vertebrasegment 210 illustrated in FIG. 11D has no guidewire channel 284, as theguidewire passes through to the guidewire channel 284 in the IVC guideafter passing through the vertebra segment 207 illustrated in FIG. 11C.Another difference in the inner structure of the vertebra segment 210 ofFIG. 11D as compared to those previously described is a pair of widerproximal articulation cable channels 294. Since previous sequentialvertebrae segments constrain the proximal articulation cables, the jointat the intersections will not flex or bend. As the proximal articulationcable channels 294 in the vertebra segment 210 of FIG. 11D are wider,they allow for the movement of the joint at the intersection of thevertebra segment 210 of FIG. 11D and the first middle link illustratedin FIG. 11E when the proximal articulation cables are pulled orreleased.

FIG. 11E is a cross section of the vertebra segment of FIG. 10. Theouter structure of this vertebra segment 212 is flat on one side toaccommodate the IVC guide shown in FIG. 10. The inner structure of thisvertebra possesses several features related to cable pathway managementthroughout the length of the flexible shaft 182. The inner structure issimilar to the vertebra segment 210 of FIG. 11D, but the vertebrasegment 212 illustrated in FIG. 11E, the first middle link, has a pairof still wider proximal articulation cable channels 310 to accommodatethe flex or bend of the proximal articulation cables. The first middlelink also defines two proximal articulation cable recesses 312, whichare configured to accommodate the termination of the proximalarticulation cables at the joint between the first middle link of FIG.11E, and the second middle link of FIG. 11F. Another difference in theinner structure of the vertebra segment 212 of FIG. 11E as compared tothe vertebra segment 210 previously described in FIG. 11D is a pair ofwider distal articulation cable channels 306. Since previous sequentialvertebrae segments 210, 207, 206 constrain the distal articulationcables 306, the joint at those intersections will not flex or bend.Since the distal articulation cable channels 306 in the vertebra segment212 of FIG. 11E are wider, they allow for the movement of the joint atthe intersection of the second middle link illustrated in FIG. 11F andthe distal tip 220 of the instrument when the distal articulation cablesare pulled or released.

FIG. 11F is a cross section of the vertebra segment 216 of FIG. 10. Theouter structure of this vertebra segment 216 is flat on one side toaccommodate the IVC guide shown in FIG. 10. The inner structure issimilar to the vertebra segment 216 of FIG. 11E, but the vertebrasegment 216 illustrated in FIG. 11F, does not have proximal articulationcable channels 310, since the proximal articulation cables terminated inthe vertebra segment 212 of FIG. 11E. Another difference in the innerstructure of the vertebra segment 216 of FIG. 11F as compared to thevertebra segment 212 previously described in FIG. 11E is a pair of stillwider distal articulation cable channels 326 to allow for the movementof the joint at the distal tip 220 of the instrument when the distalarticulation cables are pulled or released. The second middle link 212also defines two distal articulation cable recesses 324, which areconfigured to accommodate the termination of the distal articulationcables within the vertebra segment of FIG. 11F.

FIG. 12A-12B are perspective views of the unique vertebra segment ofFIG. 11B. The vertebra segment 206 illustrated in FIGS. 12A and 12Bdefines two first needle channels 256, a first suture pair path 270,surrounded by two distal articulation cable channels 258, a centrallocking cable channel 260, a guidewire channel 268, a second suture pairpath 266 surrounded by two proximal articulation cable channels 262, andsecond needle channels 264. These have been described in detail withregard to FIG. 11B. The vertebra segment 206 illustrated in FIGS. 12Aand 12B further defines a vertebra link 342 and a vertebra recess 340configured to link similar or distinct vertebra segments as describedherein, depending the desired length of chain or inner channelconfiguration of a particular embodiment. The vertebra segment 206 alsodefines a groove 338 or grooved end that is configured to provide afriction fit when the flexible shaft 182 vertebra segments 206 arelocked using the locking mechanism. The grooves 338 will enable improvedfit or immobilization of the various vertebrae comprising a flexibleshaft 182 in this embodiment of the surgical suturing device 180 asdescribed herein. FIGS. 13A-13F are front, left side, right side, rear,top, and bottom elevational views, respectively of the unique vertebrasegment of FIGS. 12A-B.

FIG. 14A-14B are perspective views of the unique vertebra segment ofFIG. 11C 207. The vertebra segment illustrated in FIGS. 14A and 14B 207defines two first needle channels 272, a first suture pair path 286,surrounded by two distal articulation cable channels 274, a centrallocking cable channel 276, a guidewire channel 284, a second suture pairpath 282 surrounded by two proximal articulation cable channels 278, andsecond needle channels 280. These have been described in detail withregard to FIG. 11C. The vertebra segment 207 illustrated in FIGS. 14Aand 14B further defines a vertebra link 348 and a vertebra recess 346configured to link similar or distinct vertebra segments 207 asdescribed herein, depending the desired length of chain or inner channelconfiguration of a particular embodiment. The vertebra segment 207 alsodefines a groove 344 or grooved end that is configured to provide afriction fit when the flexible shaft 182 vertebra segments 207 arelocked using the locking mechanism. The grooves 344 will enable improvedfit or immobilization of the various vertebrae comprising a flexibleshaft 182 in this embodiment of the surgical suturing device 180 asdescribed herein. FIGS. 15A-15F are front, left side, right side, rear,top, and bottom elevational views, respectively of the unique vertebrasegment of FIGS. 14A-14B.

FIGS. 16A-16B are perspective views of the unique vertebra segment ofFIG. 11D 210. The vertebra segment 210 illustrated in FIGS. 16A and 16Bhas a flat side and defines two first needle channels 288, a firstsuture pair path 302, surrounded by two distal articulation cablechannels 290, a central locking cable channel 276, a second suture pairpath 298 surrounded by two proximal articulation cable channels 294, andsecond needle channels 296. These have been described in detail withregard to FIG. 11D. The vertebra segment 212 illustrated in FIGS. 16Aand 16B further defines a vertebra link 354 and a vertebra recess 352configured to link similar or distinct vertebra segments 206, 207, 210,212 as described herein, depending the desired length of chain or innerchannel configuration of a particular embodiment. The vertebra segment212 also defines a groove 350 or grooved end that is configured toprovide a friction fit when the flexible shaft 182 vertebra segments206, 207, 210, 212 are locked using the locking mechanism. The grooves350 will enable improved fit or immobilization of the various vertebrae206, 207, 210, 212 comprising a flexible shaft 182 in this embodiment ofthe surgical suturing device 180 as described herein. FIGS. 17A-17F arefront, left side, right side, rear, top, and bottom elevational views,respectively of the unique vertebra segment of FIGS. 16A-16B.

FIGS. 18A-18B are perspective views of the unique vertebra segment ofFIG. 11E. The vertebra segment 212 illustrated in FIGS. 18A and 18B hasa flat side and defines two first needle channels 304, a first suturepair path 320, surrounded by two distal articulation cable channels 306,a central locking cable channel, a second suture pair path 316surrounded by two proximal articulation cable channels 310, and secondneedle channels 314. The vertebra segment 212 also defines two proximalarticulation cable recesses 310. These features have been described indetail with regard to FIG. 11E. The vertebra segment 212 illustrated inFIGS. 18A and 18B further defines a vertebra link 360 and a vertebrarecess 358 configured to link similar or distinct vertebra segments 206,207, 210, 212 as described herein, depending the desired length of chainor inner channel configuration of a particular embodiment. The vertebrasegment 212 also defines a groove 356 or grooved end that is configuredto provide a friction fit when the flexible shaft 182 vertebra segments206, 207, 210, 212 are locked using the locking mechanism. The grooves356 will enable improved fit or immobilization of the various vertebraecomprising a flexible shaft 182 in this embodiment of the surgicalsuturing device as described herein. FIGS. 19A-19F are front, left side,right side, rear, top, and bottom elevational views, respectively of theunique vertebra segment of FIGS. 18A-18B.

FIG. 20A-20B are perspective views of the unique vertebra segment ofFIG. 11F. The vertebra segment 216 illustrated in FIGS. 20A and 20B hasa flat side and defines two first needle channels 322, a first suturepair path 336, surrounded by two distal articulation cable channels 326,a central locking cable channel, a second suture pair path 332, andsecond needle channels 330. The vertebra segment 216 also defines twodistal articulation cable recesses 324. These features have beendescribed in detail with regard to FIG. 11E. The vertebra segment 216illustrated in FIGS. 20A and 20B further defines a connection end 362for attaching a distal tip 220 to the end of the flexible shaft 182, anda connection for terminating the locking cable, not shown in this view.FIG. 21A-21F are front, left side, right side, rear, top, and bottomelevational views, respectively of the unique vertebra segment 212 ofFIGS. 20A-20B.

FIG. 22 is an enlarged top view of the embodiment of a proximal end of asurgical suturing device, focusing on the control panel 374 with thecover removed. A locking control 380, shown in FIG. 22 in an unlockedposition, is connected to a locking control arm 424 attached to a pivoton the opposite side of a control panel of a surgical suturing device366. There is a catch, not shown in this view, on the underside of thelocking control 380, configured to engage in the steps of a steppedpositioning ratchet as the locking control 380 is moved through thelocking control channel 420. A locking cable, not visible in this view,as it is obscured by the first needle pair wire, having a locking cableconnection end 428 is attached to the locking control arm 424 byengaging the locking cable connection end 428 into a locking control armrecess 430, also not shown in this view. As the locking control arm 424is moved to a locking position around a pivot 426, the locking cable ispulled and therefore tensioned. This tensioning of the locking cabletensions the entire flexible shaft 182, not shown here, but previouslydescribed, locks the flexible shaft and its vertebrae into its positionwhen the locking control 380 is engaged.

FIG. 23A-23B are side views of an embodiment of an articulation controllever of the surgical suturing device of FIG. 22 shown in an engagedposition and disengaged position, respectively. FIG. 23A is a side viewof an embodiment of an articulation control lever 432 in an engagedposition. The articulation control lever 432 has a knob connected to anend of the lever 372. The lever 372 is made of a single structure asshown, having a first flexure point 436, and a second flexure point 438.A tab 440 on the underside of the lever 372 near the distal end providesleverage against a first flexure point 436 and a second flexure point tohold a key on the underside of the lever 372 adjacent to the firstflexure point 436 engaged in a keyway, in the control panel surface 446.To disengage the key 442 from the keyway 444 and subsequently move thearticulation control lever 432 to a different position, the knob 434 ispushed in a direction towards the control panel surface 446, whichutilizes the tab 440 as a pivot point to flex the first flexure point436 and the second flexure point 438 sufficiently to lift the key 442out of the keyway 444. The articulation control lever 432 is nowdisengaged and can be moved to a different position. FIG. 23B is a sideview of an embodiment of an articulation control lever 432 in adisengaged position.

FIG. 24A is a perspective view of another embodiment of a surgicalsuturing device, as described herein. The surgical suturing device 366has a housing 368 that has a handle 370, a needle selection switch, alever 372, and a suture viewing window 376. The upper portion of thehousing 368 defines a control panel 374 having a locking control 380, adistal articulation control lever 382, and a proximal articulationcontrol lever 378. Attached to the housing 368 is a flexible shaft 384composed of several vertebrae 386 and terminating in a distal tip 388and an IVC guide 390. The vertebrae are characterized by severalchannels similar to previously described embodiments, the channelsconfigured to accommodate steering wires, sutures, needles, and othercomponents for the assembly and operation of the surgical suturingdevice. The IVC guide 390 defines a guide wire channel 392.

FIG. 24B is an enlarged top-left-front top perspective view of anembodiment of a proximal end of the surgical suturing device of FIG.24A, focusing on the control panel 374 with the cover removed. Thecontrol panel 374 of the surgical suturing device 366 is shown with thedistal articulation control lever 382 and the proximal articulationcontrol lever 378 removed. The distal articulation control mechanism 396and the proximal articulation control mechanism 394 are illustrated. Theproximal articulation control mechanism 394 has an axle 404, which isrectangular in shape, and to which the proximal articulation controllever 378 is attached. The proximal articulation control mechanism 394also has a pulley and capture stack consisting of a lower pulley 412, anupper pulley 410, and a capture element 408. Each of the lower pulley412, upper pulley 410, and capture element 408 have several alignmentholes 406. The lower pulley 412, upper pulley 410, and capture element408 have fifteen alignment holes 406, sixteen alignment holes 406, andfifteen alignment holes 406, respectively. The lower pulley 412 andupper pulley 410 each define a slot to attach the ends of the twoproximal articulation control cables. One proximal articulation controlcable is wound around either the upper or lower pulley 410, 412clockwise, and the other proximal articulation control cable is woundaround the other of the upper or lower pulley 410, 412 counterclockwise.The alignment holes 406 are configured for fine adjustment of the twoproximal articulation control cables during assembly and adjustment. Thecables and associated fine adjustment details of the pulley and capturestack are not shown in this view. The distal articulation controlmechanism 396 is similarly constructed and is not described in detailherein. While this embodiment of a surgical suturing device 366 shows apulley and capture stack system of cable articulation, other means ofcable articulation known to those skilled in the art may also be used,such as a rocker arm assembly and the like. FIG. 24C is an enlargedtop-left-rear perspective of the proximal end of the surgical suturingdevice 366 of FIG. 24A, focusing on the control panel 374 with the coverremoved. It is an alternate view of the details shown in FIG. 24B.

Loading and Retrieval Apparatus

Looking back at the surgical situation illustrated in FIG. 4M, the firstend of the first suture 86 and the first end of the second suture 108were each placed through a first pledget 146 on one side of thetricuspid valve 126. Similarly, the second end of the first suture 86and the second end of the second suture 108 were each placed through asecond pledget 148 on the opposite side of the tricuspid valve 126. Forthe sake of explanation, picture a similar surgical situation, but onewhere pledgets 146 have not been installed onto the suture ends yet.This surgical situation will be discussed with respect to the apparatusof FIG. 25, by way of example.

FIG. 25 illustrates one embodiment of a loading and retrieval apparatus450 for use in installing a pledget 452 over two suture ends while alsothreading those suture ends through a mechanical fastener 460 which hasbeen loaded into a fastening device. In this embodiment, the apparatushas a curved handle 464 which is coupled to a snare 462 which passesthrough the mechanical fastener 460 and then through different portionsof a pledget 452, forming first and second snare loops 466, 468 on adistal side of the pledget 452D. In other embodiments, the snare 462 mayhave fewer or more snare loops 466, 468 coupled to the handle 476. Thecurved handle 464 may be passed into a mechanical fastening device, suchas, but not limited to, the COR-KNOT® fastening device from LSISolutions, Inc. (Victor, N.Y.) in order to load the mechanical fastener460 into the device.

Thinking of the surgical scenario outlined in regard to FIG. 4M, onesuture end, such as the first end of the first suture from ourexplanatory surgical situation may be placed through the first snareloop 468. Another suture end, such as the first end of the second suturefrom our explanatory surgical situation may be placed through the secondsnare loop 466. The curved handle 464 may then be pulled, causing thesnare loops 468, 466 to pull the suture ends back through the pledget452 and back through the mechanical fastener 460. The loading andretrieval apparatus 450 also has a tether loop 456 which passes throughthe pledget 452 and extends a distance away from the pledget 452. Inthis embodiment, the tether loop 456 also passes through a tube 458,exiting the tube 458 on a proximal end of the apparatus. Although notshown in this view so that the tether loop 456 may be seen more clearly,a tether holder 484 may be placed within the proximal end of the tetherloop 456 to prevent it from passing back into the tube 458. The tetherloop 456 and tube 458 are preferably selected to be a length which willalways ensure a portion of the tube 458 and the proximal end of thetether loop 456 are accessible from outside of the patient, even whenfirst the pledget 452 and mechanical fastener 460 and second the distalportion of a mechanical fastening device 366 holding the mechanicalfastener 460 are parachuted down the first and second sutures againstthe tricuspid valve 126.

If we consider a situation where the pledget 452 and mechanical fastener460 and the distal portion of a mechanical fastening device holding themechanical fastener 460 are parachuted down the first and second suturesagainst the tricuspid valve 126: When the pledget 452 is positionedagainst the valve annulus or other tissue and the mechanical fastener460 is crimped, the mechanical fastening device may be withdrawn,leaving a crimped mechanical fastener 460 behind, along with itscorresponding pledget 452. The resultant situation would be like thatshown in FIG. 4N, but with the addition of a tether loop 454 which isstill passing through the pledget 452 (the pledget 452 that is heldagainst the tissue by the mechanical fastener 460 crimped onto thesuture) and then up and out of the tube 458, where the proximal end ofthe tube and the proximal end of the tether loop 456 are stillaccessible outside of the patient. It should be noted that the lowerpledget 452 shown in the base scenario of FIG. 4N would not be presentin this scenario. If, for any reason, the surgeon would wish to removethe crimped fastener and pledget 452 at this point, the surgeon couldgrasp the proximal end of the tether loop 456 (and the proximal end ofthe tube 458, if a tube 458 was present in the embodiment) and pull toremove the pledget 452 attached to the tether loop 454. This would alsoremove the mechanical fastener 460, since it is held against the pledget452. This offers a big advantage for being able to reverse part of theprocedure while percutaneously retrieving the fastener 460, pledget 452,and sutures.

If, however, the surgeon was satisfied with the placement of themechanical fastener 460 and pledget 452, the surgeon could remove thetether holder (if one was present) from the proximal end of the tetherloop 456, cut the proximal end of the tether loop 456, and then pull oneend of the tether loop 456 to release the pledget 452 from the tether456. Then, the remaining length of tether 456 and tube 458 may safely beremoved from the patient, leaving the implanted pledget 452 andmechanical fastener 460 behind for the surgical repair being performed.

FIG. 26A shows another embodiment of a loading and retrieval apparatuslike that of FIG. 25, but with a tether holder 484. It is alsonoteworthy that in this embodiment, the tether loop 482 is formed by afastener holding two ends of the tether together 480. Instead of afastener, other embodiments could have the tether loop 482 formed by atied knot, an adhesive, a welding, or the like.

FIG. 26B is an enlarged view of the proximal end of the apparatus fromFIG. 26A. FIG. 26C is an enlarged proximal view of the pledget end ofthe apparatus from FIG. 26A. It should be noted that although the handle476 is curved in the illustrated embodiments, the handle 476 bin otherembodiments may have other shapes. FIG. 26D is an enlarged distal viewof the pledget end of the apparatus from FIG. 26A.

FIG. 27 is a perspective view of an alternate embodiment of the surgicalsuturing device 488 described previously. This embodiment has a housing490 which defines a handle 506, a top lever stop 500 and a bottom leverstop 502. Both the top lever stop 500 and the bottom lever stop 502define several positional keyways 504. The housing 490 has several slotswithin the top lever stop 500 and the bottom lever stop 502 that allowmovement of a first articulation lever 508 and a second articulationlever 510 towards either a distal end 488D or a proximal end 488P of thesurgical suturing device 488. The first articulation lever 508 and thesecond articulation lever 510 define one or more keys, not shown here,that engage within the positional keyways 504 in order to hold or lockthe position of the respective articulation levers 508, 510, similar inprinciple to the mechanism described in regard to FIGS. 23A and 23B. Thefirst articulation lever 508 and second articulation lever 510 areconfigured such that they can flex in a direction away from thepositional keyways 504 and can be moved to a desired position andreleased, where they are biased such that the key on the respectivearticulation lever 508, 510 engages with the appropriate positionalkeyway 504, preventing undesired movement of the articulation lever 508,510. The levers are made of either plastic or metal that can flex orbend away from the keyway 504, and when released will be biased towardthe stop mechanism or positional keyway 504 in its assembledconfiguration. This described stop or positional mechanism may alsoinclude teeth on the levers 508, 510 configured to move then rest withinthe desired locked position in gears located in the lever stops 500,502. The top of the housing 490 further defines two slots that allowmovement of the first needle driver 492 and the second needle driver 494towards either the distal end 488D or the proximal end 488P of thesurgical suturing device 488. Towards the proximal end of the housing490, a rigid shaft 518 is attached to a mount 516 attachment connectedto the housing 490. Further towards the proximal end of the surgicalsuturing device 488, a flexible shaft 520 portion is attached to therigid shaft 518, terminating in a distal tip 522 to which an inferiorvena cava (IVC) guide 524 or proboscis is attached. The IVC guide 524defines a guide wire channel 526, which also continues throughout theentire surgical suturing device 488.

FIGS. 28A-28B are top partial cross-sectional schematic views of aretracting telescope of the surgical suturing device of FIG. 27. FIG.28A is a top view showing the retracting telescope 512 portion of thesurgical suturing device 488 of FIG. 27 in a closed position. FIG. 28Ais a hidden view of the inner telescope segment 536, the middletelescope segment 538, and the outer telescope segment 540 closed orstacked or nested or collapsed coaxially within the telescope housing496. The first needle 532 and second needle 534 are held captive in theinner telescope, the details of which will be discussed later. FIG. 28Bis a top view showing the retracting telescope 512 portion of thesurgical suturing device 488 of FIG. 27 in a retracted position. Theoperator grasps the telescope handle 514, which is defined by the innertelescope segment 536, and pulls the handle 514 in a proximal direction,thereby extending the inner telescope segment 536 out from the middletelescope segment 538, and in turn the outer telescope segment 540 outfrom the telescope housing 496. This action also brings the first needle532 and the second needle 534 along with the inner telescope segment 536as the needle barrels 528 are held captive in the barrel recess 530.Once the needles 532, 534 have ferrules attached during a surgicalprocedure are, this telescope provides a mechanism for retracting theneedles, and therefore any attached ferrules or sutures from thesurgical site. This can be advantageous as a method to remotely removeneedles, sutures, or other instrumentation from a surgical site via aconstrained space, such as a small incision site or cannula. The innertelescope segment 536 also defines a stop 541 which prevents thetelescope handle 514 from nesting too far inside the middle telescopesegment 538. The inner telescope 536 further defines a barrel recess 530which releasably holds a barrel from one or more needles. This barrelrecess 530 will be described in more detail later. While each of theinner telescope segment 536, middle telescope segment 538, and outertelescope segment 540 shown here are tubular, with right angle sidewalls, it should be noted that tubular members or structures withrounded, cylindrical, or circular side walls may be used in similarembodiments. It should also be noted that although three segments areused herein, embodiments with only two telescope segments or multipletelescope segments may also be used.

FIG. 29 is a perspective view of another embodiment of a surgicalsuturing device 544 as described herein. This embodiment has a housing546 which defines a handle 556, a top lever stop 570 and a bottom leverstop 572. Neither the top lever stop 570 nor the bottom lever stop 572have positional keyways as in previous embodiments, but have internalgear stops, not shown in this view, to engage corresponding tabs on afirst articulation lever 560 and a second articulation lever 562. Thehousing 546 has several slots within the top lever stop 570 and thebottom lever stop 572 that allow movement of the first articulationlever 560 and the second articulation lever 562 towards a distal end544D or a proximal end 544P of the surgical suturing device 544. Thefirst articulation lever 560 and the second articulation lever 562define one or more tabs, not shown in this view, that engage within theinternal gear stops to hold or lock the position of the respectivearticulation levers 560, 562. The first articulation lever 560 andsecond articulation lever 562 are configured such that they can flex ina direction away from the gear stops and can be moved to a desiredposition and released, where they are biased such that the key on therespective articulation lever engages with the appropriate gear stop,preventing undesired movement of the articulation lever. This describedmechanism may also include positional keyways as described in regard toprevious embodiments. The first or upper articulation lever 560, 562adjusts the position of the flexible portion of the shaft 580 and thesecond or lower articulation lever 560, 562 adjusts the position of thedistal tip 582, which will be described later in greater detail. The topof the housing 546 further defines two slots that allow movement of afirst needle driver 566 and a second needle driver 564 towards eitherthe distal end or the proximal end of the surgical suturing device 544.Towards the proximal end of the housing 546, a rigid shaft 578 isattached to a mount 576 held captive in the housing 546. Further towardsthe proximal end of the surgical suturing device 544, a flexible shaft578 portion is attached to the rigid shaft 578, terminating in a distaltip 582 to which an inferior vena cava (IVC) monorail guide 584 orproboscis is also attached. The distal tip 582 defines a first tissuegap and a second tissue gap, which in this embodiment are symmetricaland facing opposite directions. The flexible IVC monorail guide 584defines a guide wire channel 586, which also continues throughout theentire surgical suturing device 544.

FIGS. 30A-30H, 30J-30N, 30P-30AH, 30AJ-30AN, and 30AP are exploded viewsillustrating an assembly sequence of the surgical suturing device 544 ofFIG. 29. FIG. 30A is an exploded view illustrating an assembly step ofthe surgical suturing device 544 of FIG. 29, depicting the assembly ofthe flexible shaft portion 580. The flexible shaft 580 is constructed byattaching several vertebrae together by way of slidably connecting avertebra link into a vertebra recess 600 on a subsequent vertebrasegment. The proximal link 588 or last vertebra of the shaft 580 isslidably connected to the first middle link 590 and subsequently to thesecond middle link 592, the third middle link 594, the fourth middlelink 596, and the distal jaw link 598 in the same manner. The proximallink 588 defines a recessed portion 602 configured to insert within therigid shaft 628 portion. Each vertebra further defines channelstherethrough to accommodate the sutures, needles, guide wire,instrumentation, and other features of the surgical suturing device 544which will be described in more detail later in regard to FIGS. 44-57F.FIG. 30B is a perspective view of the assembled flexible shaft 580.

FIG. 30C is an exploded view illustrating an assembly step of thesurgical suturing device 544 of FIG. 29, depicting the assembly of theshaft 580. First, several inner shaft segments 624, which make up theinner portions of the shaft are inserted into a rigid shaft 628. Thenthe flexible shaft portion 580 as assembled and shown in FIG. 30B ispartially inserted into the rigid shaft 628 along an axis 626 as shown.At the opposite end of the rigid shaft 628, a rigid tube adapter 630 isinserted into the rigid shaft 628 along an assembly axis 626. Theopposite end of the rigid tube adapter 630 is inserted into a tubebolster 632, into which a shaft mount 634 is inserted on the oppositeend of the tube bolster 632. These segments and components are allfixedly attached by friction fit, welding or adhesion using a suitableadhesive or other assembly means known toiled in the art. It should benoted that each component shown defines channels corresponding to thearrangement of the needles, sutures, guide wire, and steering cables inthe surgical suturing instrument 544 described herein. The inner shaftsegment 624 may be composed of either one single inner shaft segment624, or multiple inner shaft segments 624 of varying lengths as long asthe inner shaft segments 624 are likewise configured with channels forthe guide wire, the sutures, the steering cables, the needles, and anyother components. FIG. 30D is a perspective view of the assembly stepsillustrated in FIGS. 30A-30C.

FIGS. 30E and 30F are exploded views illustrating another series ofassembly steps of the surgical suturing device 544 of FIG. 29. In FIG.30G, two lower steering cables 652 are inserted into steering cablechannels 642 as defined by the shaft mount 634 from the previousassembly steps. The shaft mount 634 also defines a guide wire channel646. The shaft mount 634 also defines two suture passages through whichsutures can freely pass during the operation of the surgical suturingdevice 544. The shaft mount 634 further defines several steering cableschannels 642 that continue throughout the rigid shaft 628 and flexibleshaft portion 580. Upon insertion to the end of the flexible shaftportion 580, the ends of each of the upper and lower steering cables652, 656 are each fixedly attached to a coupler 638 to hold the steeringcable captive at the distal end of the flexible shaft 580 illustrated inFIGS. 30E and 30F. The shaft mount 634 also defines an upper mount slot650 and a lower mount recess 648.

FIG. 30H is an exploded view illustrating an assembly step of thesurgical suturing device of FIG. 29, depicting the assembly of thesecond or lower articulation lever sub-assembly. FIG. 30H shows the twolower steering cables 656, 652 from the previous assembly stepsterminating in their respective couplers 658 extending from the shaftmount 634. The coupler 658 of the left lower steering cable 652 isinserted into a recess 636 defined by a lower pulley 662. The lowerpulley 662 further defines a central hole 678 and several alignmentholes 674, 680. The coupler 654, 658 of the right lower steering cable652 is inserted into a recess 636 defined by an upper pulley 660. Theupper pulley 660 also further defines a central hole 672 and severalalignment holes 674. A second lower articulation lever 666 defines astop tab 668 and a pulley section 664 with a center hole 682 andmultiple alignment holes 684. The central holes 678, 672 of the secondlower articulation lever 666, the lower pulley 662 and the upper pulley660 are then stacked with their respective central holes aligned. Thistemporarily captures the couplers of the two steering cables in therecesses of their respective pulleys and in the second lowerarticulation lever 666 subassembly. FIG. 30J is a perspective viewillustrating the result of the assembly step of FIG. 30H. FIG. 30I isnot used or shown because the letter I may be mistaken for the numeral1. FIG. 30J shows the alignment of the hole in the pulley section 664 asassembled in FIG. 30H with a lower pulley mount 690 having a centralhole and a pulley mount tab 692. The pulley mount tab 692 is alsoinserted and fixedly attached to the mount recess 648 on the shaft mount634. FIG. 30H also shows the second lower articulation lever 666, stoptab 668, pulley section 664, center hole, and attached steering cables656, 652 in their sub assembly orientation. FIG. 30K illustrates thesecond lower articulation lever 666 subassembly step as completed inFIG. 30J, adding a screw to fixedly attach the pulley system 686 to thelower pulley mount 690.

FIG. 30L-30M are a series of exploded views illustrating another seriesof assembly steps of the surgical suturing device 544 of FIG. 29. Asshown in FIGS. 30L and 30M, two couplers 638, only one of which is shownhere, are inserted into several corresponding recesses 636 in the distalend of the flexible shaft 580. In FIG. 30N, two upper steering cables700, 706 are inserted into the upper steering cable channels 698 asdefined by the shaft mount 634 shown in the previous assembly steps.FIG. 30O is not used to avoid confusion with the number 300. FIG. 30P isan exploded view illustrating an assembly step of the surgical suturingdevice of FIG. 29, depicting the assembly of the first or upperarticulation lever 710 sub-assembly. FIG. 30L shows the two uppersteering cables 700, 706 from the previous assembly steps terminating intheir respective couplers 708, 702 extending from the shaft mount 634.The coupler 708 of the left upper steering cable 706 is inserted into arecess 724 defined by a lower pulley 718. The lower pulley 718 furtherdefines a central hole 740 and several alignment holes 732. The coupler708 of the right upper steering cable 706, 700 is inserted into a recess730 defined by an upper pulley 716. The upper pulley 716 also furtherdefines a central hole 720 and several alignment holes 722. A firstupper articulation lever 710 defines a stop tab 712 and a pulley section714 with a center hole 720 and multiple alignment holes 722. The centralholes 720, 726, 740 of the first upper articulation lever 710, the upperpulley 716 and the lower pulley 718 are then stacked with theirrespective central holes 726, 740 aligned. This temporarily captures thecouplers 708, 702 of the two steering cables 700, 706 in the recesses724, 730 of their respective pulleys and in the first upper articulationlever 710 subassembly. FIG. 30Q illustrates the first upper articulationlever 710 subassembly step as completed in FIG. 30P, adding a screw tofixedly attach the pulley system 742 to the lower pulley mount 690. FIG.30R is a perspective view of the result of the assembly steps of FIGS.30G-30P.

FIG. 30S is an exploded view illustrating an assembly step of thesurgical suturing device of FIG. 29, depicting the assembly of the upperneedle pair. Two flexible needles 748, each having ferrule engaging tips750, 754, are inserted into two holes 758, 762 defined by a distalneedle barrel 756, and subsequently into two holes 758, 762 defined by aproximal needle barrel 760. The distal needle barrel 756 and theproximal needle barrel 760 are fixedly attached to the needle pair 764,with the needle assembly terminating in the proximal needle barrel 760.FIG. 30J is a perspective view of the upper needle pair 764 assembly ofFIG. 30S.

FIG. 30U is an exploded view illustrating an assembly step of thesurgical suturing device of FIG. 29, depicting the assembly of thesecond upper needle pair 764 and the second needle drive lever 766. Asecond needle drive lever 766 defining a recess 770, a pivot hole 774, abarrel catch 768, and a spring catch 772 accepts the second upper lowerneedle pair 764 assembly of FIG. 30T into the recess 770, and releasablyholds the distal barrel 756 of the second upper needle pair 764 assemblyin the barrel catch 768 defined by the second needle drive lever 766.The needle pair 764 are allowed to travel freely within the recess 770during operation of the surgical suturing device 544. The spring catch772 is configured to connect a spring from the first needle drive leverto the housing of the surgical suturing device 544 and the pivot hole774 is configured to constrain the rotation and allow pivotal movementof the second needle drive lever 766 around a captive pin in the housingof the surgical suturing device 544. These will be discussed in furtherdetail later. FIG. 30V is a perspective view illustrating the result ofthe assembly step of FIG. 30U, showing the assembled configuration ofthe second upper lower needle drive subassembly, and the distal barrel756 of the needle pair held within the barrel catch 768 of the secondupper needle drive. Needle drive levers as described herein may also bereferred to as needle actuators.

FIG. 30W is an exploded view illustrating an assembly step of thesurgical suturing device of FIG. 29, depicting the assembly of the lowerneedle pair. Two flexible needles 780, each having ferrule engaging tips778, 782, are inserted into two holes 786, 790 defined by a distalneedle barrel 784, and subsequently into two holes 786, 790 defined by aproximal needle barrel 788. The distal needle barrel 784 and theproximal needle barrel 788 are fixedly attached to the needle pair 792,with the needle assembly terminating in the proximal needle barrel 788.FIG. 30X is a perspective view of the lower needle pair 792 assembly ofFIG. 30W.

FIG. 30Y is an exploded view illustrating an assembly step of thesurgical suturing device of FIG. 29, depicting the assembly of the firstlower needle pair and the first needle drive lever. A first needle drivelever 794 defining a recess 798, a pivot hole 802, a barrel catch 796,and a spring catch 800 accepts the first lower needle pair 792 assemblyof FIG. 30X into the recess 798, and releasably holds the distal barrel784 of the first lower needle pair 792 assembly in the barrel catch 796defined by the first needle drive lever 794. The needle pair 792 areallowed to travel freely within the recess 798 during operation of thesurgical suturing device 544. The spring catch 800 is configured toconnect a spring from the first needle drive lever 794 to the housing ofthe surgical suturing device 544 and the pivot hole 802 is configured toconstrain the rotation and allow pivotal movement of the first needledrive lever 794 around a captive pin in the housing of the surgicalsuturing device 544. These will be discussed in further detail later.FIG. 30Z is a perspective view illustrating the result of the assemblystep of FIG. 30Y, showing the assembled configuration of the first lowerneedle drive subassembly, and the distal barrel 784 of the needle pair792 held within the barrel catch 796 of the first lower needle drive.

FIG. 30AA is an exploded view illustrating an assembly step of thesurgical suturing device of FIG. 29, depicting the assembly of theretracting telescope. An inner telescope segment 804 defines a stop, twodistal stops 822, 824 (one on either side) and a handle towards theproximal end 814 of the inner telescope segment 804. At the distal end816 of the inner telescope segment 804, the inner telescope segment 804defines two needle slots 810 and a barrel recess 808. Two middletelescope segment halves 818A, 818B are assembled over the innertelescope segment 804, these middle telescope segments 818A, 818Bconfigured to enclose the inner telescope segment 804, yet allowslidable nesting such that the inner telescope segment 804 may be pulledtowards the proximal end 814 and slide the inner telescope segment 804outward. The stop defined by the inner telescope segment 804 isconfigured to prevent the inner telescope segment 804 from beinginserted too far into the middle telescope segment 818A, 818B. Thedistal stops 812, 822, 824, on the inner telescope segment 804 preventthe inner telescope from sliding too far proximal and out of the middletelescope segment 818A, 818B once assembled, thus holding it captive.The middle telescope segments 818A, 818B also define two distal stops822, 824 and combine to form a proximal stop 826. Two outer telescopesegment halves 820A, 820B are assembled over the middle telescopesegment 818A, 818B, these outer telescope segments 820A, 820B configuredto enclose the middle telescope segment 818A, 818B, yet allow slidablenesting such that the middle telescope segment 818A, 818B may be pulledtowards the proximal end 814 and slide the middle telescope segment818A, 818B outward. The stop defined by the middle telescope segment818A, 818B is configured to prevent the middle telescope segment818A,818B from being inserted too far into the outer telescope segment820A, 820B. The distal stops 822, 824 on the middle telescope segment818A, 818B prevent the middle telescope from sliding too far proximaland out of the outer telescope segment 820A, 820B once assembled, thusholding it captive. The outer telescope segments 820A, 820B also definetwo distal stops 822, 824 and combine to form a proximal stop 828. Thestop defined by the outer telescope segment 820A, 820B is configured toprevent the outer telescope segment 820A, 820B from being inserted toofar into the instrument housing. The distal stops 822, 824 on the outertelescope segment 820A, 820B prevent the outer telescope from slidingtoo far proximal and out of the instrument housing once assembled. Thetelescoping segment is configured to allow a proximal extension of eachretracting telescope segment, which allows a stationary location of thesurgical suturing device 544 within a patient during a minimallyinvasive surgical procedure, while also allowing the retraction of oneor more needle pair from the surgical site. While this embodiment of asurgical suturing device 544 shows this particular retracting telescopeand its telescoping function for the removal of one or more pair ofneedles from a surgical site, it could be configured or employed inalternate embodiments to allow for the retraction and removal from asurgical site of additional pair of needles or other instrumentation orimplements used in minimally invasive surgical 544 procedures. FIG. 30ABis a perspective view illustrating the result of the assembly step ofFIG. 30AA, showing the retracting telescope subassembly, and theassembled location of the barrel recess 808 and needle slots.

FIG. 30AC is an exploded view illustrating an assembly step of thesurgical suturing device of FIG. 29, depicting the assembly of thesuture storage housing. A suture storage housing 548 defines a suturerecess 832 having two suture passages 844, 846 that communicate throughthe suture storage housing 548 and through to the suture passages 844,846 on the shaft mount illustrated previously. The suture recess 832 ofthe suture storage housing 548 further defines a left outer suture looprecess 842, a left inner suture loop recess 840, a right outer sutureloop recess 838, a right inner suture loop recess 836, and several holes848, 850 for attaching screws 852 or other fasteners. A suture viewingwindow 834, which defines two holes 848, 850 and is transparent forvisualizing the state of the suture during the procedure is configuredto be inserted into the suture recess 832 and attached by the screws 852into several threaded holes 848, 850 defined by the suture recess 832.FIG. 30AD is a perspective view illustrating the result of the assemblystep of FIG. 30AC, showing the assembled suture storage housing 548.

FIG. 30AE is an exploded view illustrating an assembly step of thesurgical suturing device of FIG. 29. The first proximal barrel of thefirst needle drive assembly 794 is inserted into the barrel recess 808of the retracting telescope 830, with the needle pair being held in theneedle slots of the retracting telescope. The second proximal barrel ofthe second needle drive assembly 766 is likewise inserted into thebarrel recess 808 of the retracting telescope 830, with the needle pairbeing held in the needle slots of the retracting telescope 830. Finally,the suture storage housing 548 is placed on top of the retractingtelescope 830 and held in place until a subsequent subassembly step.FIG. 30AF is a perspective view, illustrating the result of the previoussubassembly steps.

FIG. 30AG is an exploded view illustrating an assembly step of thesurgical suturing device of FIG. 29, depicting the assembly of theresult of the assembly steps of FIG. 30R and FIG. 30AP. The two needlepair are inserted into the needle passages in the shaft mount (not shownhere, but more clearly depicted in FIG. 30G) and further into the entirerigid and flexible shaft portions of the surgical suturing device. FIG.30AH is a perspective view, illustrating the result of the subassemblystep depicted in FIG. 30AG. FIG. 30AI is not used or shown because theletter I may be mistaken for the numeral 1.

FIG. 30AJ is an exploded view illustrating an assembly step of thesurgical suturing device of FIG. 29, depicting the assembly of thedistal tip 582 onto the end of the flexible shaft 580. Onto the distalend of the flexible shaft 580D, the protruding needles 748, 752 fromprevious subassembly steps are visible. The distal tip 582 defines anupper recess 856, a lower recess 858, and a central channel 860. Anupper needle track 862 is inserted into the upper recess 856 defined bythe distal tip 582 and a lower needle track 866 is inserted into thelower recess 858 defined by the distal tip 582. The upper and lowerneedle tracks 862, 866 define needle paths 864, 868 for further guidingthe flexible needles 748, 752 through the distal tip 582 needlechannels, which are not shown in this view, but are described later. Itshould be noted that while the needle paths from the flexible shaft 580through to the distal tip 582 are defined by several components, thiseffect could also be accomplished with a single component or singledistal tip 582 having the upper needle track 862 and lower track 866 aspart of the distal tip 582.

FIG. 30AK is an exploded view illustrating an assembly step of thesurgical suturing device of FIG. 29, depicting an assembly step of thesurgical suturing device 544. The subassembly of FIG. 30AJ is shown. Afirst handle half 872 defines several holes 874, 876 for mounting aneedle driver pin 880 and a spring pin 878. The needle driver pin 880 isinserted into the pivot hole of each needle drive lever as thesubassembly of FIG. 30AJ is placed in the first handle half 872. FIG.30AL shows the second needle drive spring being attached to the secondneedle drive spring catch 772 on the second needle drive lever andplaced on the spring pin 878. FIG. 30AM shows the first needle drivespring 884 being attached to the first and needle drive levers. Theopposite end of each spring is mounted over the spring pin 878. Thesecond handle half 886 is placed over the other components, with theneedle driver pin 880 and the spring pin 878 being inserted intocorresponding holes (not shown) in the second handle half 886. The firstand second handle halves 886 are then fixedly attached, completing theassembly of the instrument. The first and second handle half 886 can beattached by adhesives, ultrasonic welding, or other fastening means andmethods known to those skilled in the art.

FIG. 30AN is an exploded view illustrating an assembly step of thesurgical suturing device of FIG. 29, depicting the assembly of the IVCguide wire distal channel and the IVC monorail guide 584. IVC guide wiredistal channel, IVC monorail guide 584. FIG. 30AP is an alternateperspective view of the completed surgical suturing instrument of FIG.29.

FIG. 31A is a top-left-rear perspective view of a portion of thesurgical suturing device 544 of FIG. 29 focusing on the top of thehandle and the suture viewing window. The suture viewing window 834 is atransparent window used to view the state of the sutures within thedevice and to attain visual confirmation of tissue bites or stitchestaking place when operating the device. The suture viewing window 834allows the operator to view the state of the sutures 894, 898, 902, 906and determine the completion of the operating steps during use. When theneedle pairs are driven and the ferrules are engaged by the needles attheir tips (not shown in this view), the suture loops 892, 896, 900, 904pull forward towards the distal end of the device. The first lowerneedle bite pulls the more distal or inner suture loops distally (moreforward) as a visual indication of ferrule or needle cap engagement ontothe needle. The second upper needle bite pulls the more proximal orouter suture loops 896, 904 distally (more forward) as an indication offerrule or needle cap engagement onto the needle. When the first bite ofthe lower needle set of the instrument is complete, one end of the blueor left inner suture 902 and one end of the white or right inner suture894 will have advanced in a slightly distal direction within the sutureviewing window 834. When the second bite of the upper needle set of theinstrument is complete, one end of the blue or left outer suture 906 andone end of the white or right outer suture 898 will have advanced in aslightly distal direction within the suture viewing window 834.

FIGS. 31B and 31C are top-left-front perspective views of the distal tipof the surgical suturing instrument 544 of FIG. 29. While the sutureorganization through shaft and at tip are similar to views shown inFIGS. 3A-3E, the suture ends 894, 898 corresponding to the suture loopsshown in FIG. 31A are illustrated here.

FIG. 32A and FIG. 32B are perspective views of the distal tip 582 of thesurgical suturing device of FIG. 29. The distal tip 582 has a tip body912 which defines an instrument channel 914 along one side of the tipbody 912. This instrument channel 914 is configured to releasably holdvarious instrumentation used in a minimally invasive surgical procedurefor treatment of tricuspid regurgitation. The instrument channel in thedistal tip 582 is also in communication with the instrument channel 914that is formed by the various segments or vertebrae of the flexibleshaft portion. This channel continues back to the proximal end of thesurgical suturing instrument 544. An example of an instrument used inthis instance is an intracardiac echocardiography (ICE) probe which isuseful in aiding visualization of various surgical procedure steps inthe treatment of tricuspid regurgitation. Other instrumentation may alsobe configured for use within the instrument channel 914 forvisualization, tissue grasping, or other uses within a minimallyinvasive surgical procedure. A flexible grasper may be useful inbringing tissue in closer proximity to either of the upper tissue bitearea 908 or the lower tissue bite area 910 of the distal tip 582. Thetip body 912 further defines two upper needle channels 916 and two lowerneedle channels 918 configured to guide the two pair of flexible needlesacross an upper tissue bite area 908 and a lower tissue bite area 910,respectively, to engage and pick up their corresponding ferrules andtherefore the attached suture ends in the surgical suturing device 544.Towards the distal end 582D of the distal tip 582 is a tip support 920or strut that defines an upper tissue bite area 908 and a lower tissuebite area 910. At the distal end 582D near the tip support 920, there isa tip head 922 that defines two suture passages, four suture guides 924,and four ferrule holders 928 for organizing and holding suture andferrules in the distal tip 582 and along the shaft. The suture passagesare in communication with and tunnel through from the distal tip head922 to the tip support, further through the distal tip body 912 andthrough the shaft and back to the handle in the surgical suturinginstrument 544. The suture may alternately follow an internal paththrough various channels within the distal tip 582 or be closely held incontact with the via suture holding features or guides along the distaltip 582. This distal tip 582 may have differing numbers of suturepassages, suture guides, and ferrule holders depending on therequirements of a minimally invasive surgical procedure in which theinstrument may be employed. FIGS. 33A, 33B, 33C, 33D, 33E, and 33F arefront, left side, right side, rear, top, and bottom elevational views,respectively, of the distal tip shown in FIGS. 34A and 34B. Thearrangement and pathways of the various sutures are arranged through thedistal tip 582 suture passages and held within the suture guides in thetip head 922, traveling back through the entire distal tip 582 andthrough the shaft. This arrangement is similar to that described inregard to FIGS. 3A-3E.

FIGS. 34A-D are a series of top-views of the surgical suturing device ofFIG. 29, illustrating the articulation of the flexible shaft and distaltip of the surgical suturing device. FIG. 37A is a top-view of thesurgical suturing device 544 of FIG. 29 illustrating the articulation ofthe flexible shaft 580. The top or first articulation lever 560 is movedforward toward the distal end of the surgical suturing device 544. FIG.34B is a top-view partial cross-sectional view of the surgical suturingdevice 544 of FIG. 29 demonstrating the state of the flexible shaft 580portion when the first articulation lever 560 is fully articulatedforward. A first articulation pulley system is rotatedcounter-clockwise, which in turn pulls a first left steering cableproximally. This movement articulates the flexible shaft 580 portioninto an approximate ninety-degree angle to the left while leaving thedistal tip 582 straight relative to the flexible shaft 580 portion.FIGS. 34C and 34D are top-view partial cross-sectional views of thesurgical suturing device 544 of FIG. 29 demonstrating the state of thedistal tip 582 portion when the lever is fully articulated forward andfully articulated backward, respectively. In FIG. 34C, the secondarticulation lever 562 is fully pushed forward, thereby placing a secondarticulation pulley system in a more counterclockwise position, pullinga second left steering cable proximally. The cables are not shown here,but have been described previously. This articulates the distal tip 582into an approximate thirty-degree angle in the left direction relativeto the flexible shaft 580. In FIG. 34D, the second articulation lever562 is fully pushed backward, thereby placing the second articulationpulley system in a more clockwise position, pulling a second rightsteering cable proximally. This articulates the distal tip 582 into anapproximate 30-degree angle in the right direction relative to theflexible shaft 580. These articulating controls, in addition to a simplerotation of the handle of the surgical suturing device 544, can be usedin combination to allow for several degrees of freedom of movement forthe purpose of placing stitches in desired positions within the annulusof the tricuspid valve, or in other surgical procedures as required.While these are the extreme positions of the flexible shaft 580 anddistal tip 582 for this embodiment, other embodiments may travel furtherin their respective directions of in differing ranges of motion.Further, articulation in different directions or planes relative to aplane defined by the location of the rigid shaft may also be realized inalternate embodiments of the described surgical suturing device 544.While cable steering is used in this embodiment, other methods andmaterials for steering or articulation may be used, including the use ofrigid rods, stranded or braided cable, strings, fiber or other thinflexible components.

FIGS. 35A-35G are side partial cross-sectional views of the surgicalsuturing device of FIG. 29 illustrating the operation principles of theneedle drivers and retracting telescope. FIG. 35A illustrates the stateof the handle and needle drive levers prior to any needle drivingoperations. Both the first needle driver lever 566 and the second needledriver lever 766 are in a proximal position relative to the surgicalsuturing device 544. FIG. 35B is an enlarged view of the distal tip 582.

FIG. 35C is a side-view partial cross-sectional view illustrating theleft or first needle driver lever 566 moved forward in a distaldirection. This motion of the lever pivots the lever 566 around thelever pivot 802 and brings the barrel catch 796 towards a distaldirection, which also brings the distal needle barrel 784 forward in amore distal direction. As the distal needle barrel 784 is attached tothe lower flexible needle pair 792, this drives the lower needlesforward into the lower tissue bite area 910 of the distal tip 582 of thesurgical suturing instrument 544 and across to the ferrule holders,where the flexible needle tips of the lower needles engage the lowerferrules. During a minimally invasive surgical procedure such astricuspid annular plication as described herein, the needles will firstpierce the tissue of the annulus. In this position of the first needledriver lever 566, the first spring 884 is in a stretched configuration.This stretched configuration may assist in returning the first needledriver lever 566 to its starting position, which is shown in FIG. 35A.FIG. 35D is an enlarged side-view of the distal tip 582 area of thesurgical suturing device 544 of FIG. 35C. In this enlarged side-view,the lower needle pair 792 is shown advanced distally through the lowertissue bite area 910, where it engages the lower pair of ferrules heldin the ferrule holders of the tip head of the distal tip 582. Once theneedle tips are engaged with the ferrules, they will pull the sutureattached to the ferrules back through the tissue. The ferrules andferrule holders are not indicated or visible in this view, but thefunction and use of ferrules and ferrule holders described elsewhereherein and is well-known in the art.

FIG. 35E is a side-view partial cross-sectional view illustrating theleft or first needle driver lever 566 moved back to its initialposition. This return stroke motion of the lever pivots 802 the leveraround the lever pivot 802 and brings the barrel catch 796 back towardsa proximal direction, which also brings the distal needle barrel 784back in a more proximal direction. As the distal barrel 784 is attachedto the lower flexible needle pair 792, this pulls the lower needles backinto the tip body of the distal tip 582 of the surgical suturinginstrument 544, bringing the engaged ferrules and attached suture backthrough the lower tissue bite area of the distal tip 582, and thusthrough the targeted tissue. While this position depicted in FIG. 35E issimilar to the position of the surgical suturing device 544 illustratedin FIG. 35A, the enlarged side-view of the distal tip 582 area shown inFIG. 35F illustrates the position of the lower needles which would haveengaged ferrules 938 now retracted and attached suture 940 now spanningthe lower tissue bite area. In a surgical situation, these lower sutures940 would be stitched through the tissue positioned within the lowertissue bite area of the distal tip 582 before the needles were deployed.Once the sutures are pulled back through the tissue bite area, thedifferent position of the first needle bite sutures, or the left blueinner suture loop and the right white inner suture loop can also beviewed in the suture viewing window described in regard to FIG. 31A-31C.Once the flexible needle pairs 792 are in the retracted or proximalposition, the proximal barrel 788 is handed off to the barrel recess808, which is defined by the inner telescope portion 804. The arctraveled by the rounded portion of each needle drive levers or needleactuators allows the distal barrel 784 on each needle pair to freelymove in a proximal direction. This actuation movement also moves theproximal barrel 788 attached to the needle pair 792 into the recess 808of the inner telescope segment 804, and likewise moves each needle pair792 into the needle slots in the inner telescope segment 804. At thispoint, the inner telescope portion 804 is moved back slightly bygrasping the telescope handle and pulling in a proximal direction, whichpulls out a small amount of suture through the shaft and around the headof the distal tip 582. This provides an amount of slack in the sutureline, insuring the flexible shaft and distal tip can be articulated tothe next location for placement of the upper tissue bite area where thesecond needle bite with the upper needles can take place. While notshown in this view, all described function and movement also happenswith the right needle as well, even though only the left needle is shownin this series of side-view partial cross-sectional views. Once thereturn stroke depicted in FIG. 35E is completed, the handle, theflexible shaft, and the distal tip 582 are manipulated by the surgeon oroperator to position the upper tissue bite area of the distal tip 582 ofthe surgical suturing device 544 to the desired location for the secondneedle bite, referring to the surgical procedure described in regard toFIGS. 4A-4R and 5.

FIG. 35G is a side partial cross-sectional view of the surgical suturingdevice 544 of FIG. 29. Once both needle bites have been taken, placingboth sutures in both locations of the tricuspid annulus during theprocedure described herein, the proximal barrels 788 of both sets offlexible needles are held within the inner telescope portion 804 of theretracting telescope of the surgical suturing device 544. Once thedesired sutures are made and all preliminary visual or conductiontesting is complete and meets the satisfaction of the surgeon, thesutures 940 can be payed out from the patient. By grasping the telescopehandle and pulling in a proximal direction while maintaining theposition of the handle of the surgical suturing device 544, the proximalbarrels 788 now handed off to the barrel recess 808 within the innertelescope segment 804 and therefore the flexible needles with theferrules 938 and the respective sutures 940 attached at the needle tipsby the ferrules 938 attached to the suture ends, can be pulled from thesurgical site by pulling proximally 942 and retracting the telescopethrough each nested segment—the inner telescope segment 804, then themiddle telescope segment 818, and finally the inner telescope segment804. Once the suture 940 is pulled away from the surgical site and outof the patient, the handle can also be pulled in a proximal direction942 and towards the extended, retracted telescope, thus removing thesurgical suturing device from the patient completely, leaving thepledgeted sutures extending from the surgical site. It should be notedthat throughout the operative steps described in the preceding figuresneedles and sutures 940 are held within plastic tubes or suture tubes tofacilitate motion around bends and to reduce frictional forces.Alternate embodiments may be assembled without plastic tubes enclosingthe flexible needles or sutures or may use other methods such aslubricants or alternate internal channel feature design to facilitatemotion of the cables, needles and sutures along the pathway from theproximal end of the instrument towards the distal end of the surgicalsuturing instrument or vice versa.

FIG. 36 is a top view of the flexible shaft portion of the surgicalsuturing device of FIG. 29, detailing a number of unique vertebraesegments or links, the cross-sections of which are shown in greaterdetail in FIGS. 37A-F. These vertebrae segments, when connected,comprise the flexible shaft of the surgical suturing device of thepresent disclosure. Illustrated in FIG. 36 is a first vertebraeindicated by cross-sectional marker 37A, several vertebrae segmentsindicated by cross-sectional markers 37B, 37C, and 37D, a first middlelink indicated by cross-sectional marker 37E, and a second middle linkindicated by cross-sectional marker 37F. The first vertebrae, indicatedby cross-sectional marker 37A, includes a linking end to fixedly attachthe flexible shaft to the rigid shaft of the surgical suturing device.The cross-sectional features of these vertebrae are further discussed inregard to FIGS. 37A, 37B, 37C, 37D, 37E, and 37F. The cross-sectionalfeatures shown in this embodiment of the surgical suturing device areone arrangement, and it should be noted that other arrangements orconfigurations may be useful or effective in maintaining andarticulating the various control and steering cables, sutures, guidewire, and needle pairs or sets along the internal path of a flexibleshaft may be known to those skilled in the art.

FIG. 37A is a cross section of the vertebra segment of FIG. 36. Theinner structure of the first vertebra 944 possesses several featuresrelated to pathway management throughout the length of the flexibleshaft. The vertebra segment 944 defines an upper needle channel 964 anda lower needle channel 956 which are configured to guide the firstneedle pair along the flexible shaft. The vertebra segment 944 alsodefines a first suture pair passage 968 and a second suture pair passage972, as well as channels for the upper (flexible shaft) steering cables962, 966 and for the lower (distal tip) steering cables 958, 974. Thevertebra segment or link of FIG. 37A also defines an instrument channel960 and a guide wire channel 970. It should be noted that the internalpath of the guidewire terminates at the link or vertebra segment of FIG.37A, allowing the flexible shaft portion and distal tip to articulatewhile maintaining an instrument reference position within the IVC by theguidewire.

FIGS. 37B and 37C represent an identical link or vertebra segment,though they are located adjacent to one another. FIG. 37B is a crosssection of the vertebra segment 946 indicated in FIG. 36. The innerstructure of this vertebra possesses several features related to cablepathway management throughout the length of the flexible shaft. Theinner structure is similar to the inner structure of the vertebra 944illustrated in FIG. 37A, however, the vertebra segment 946 of FIG. 37Bdoes not have a guidewire channel as in the vertebra segment of FIG.37A. The vertebra segment 946 of FIG. 37B is identical to that of thevertebra segment 948 of FIG. 37C. The inner structure of the vertebrasegments of FIGS. 37B and 37C have instrument channels 960, as well aschannels for the upper needle pair 964, lower needle pair 956, the uppersuture passage 968, lower suture passage 972, the upper steering cables962, 966 for the flexible shaft, and the lower steering cables 958, 974for the distal tip.

FIG. 37D is a cross section of the indicated vertebra segment of FIG.36. The inner structure of this vertebra possesses several featuresrelated to cable pathway management throughout the length of theflexible shaft. The inner structure is similar to the vertebraeillustrated in FIGS. 37A-37C, but the vertebra segment 950 illustratedin FIG. 37D has two recesses 976, 978 that terminate and are configuredto hold the lower flexible shaft steering cable couplers. The innerstructure of the vertebra segment of FIG. 37D also defines channels forthe upper needle pair 964, lower needle pair 956, the upper suturepassage 968, lower suture passage 972, the upper steering cables 962,966 and lower steering cables 958, 974 for the distal tip.

FIG. 37E is a cross-section of the indicated vertebra segment of FIG.36. The inner structure of this vertebra 952 possesses several featuresrelated to cable pathway management throughout the length of theflexible shaft. The inner structure is similar to the vertebra segment950 of FIG. 37D, but the vertebra segment 952 illustrated in FIG. 37E,contains no inner structure or features related to the flexible shaftsteering cables, as they terminated in the vertebra link 950 describedin regard to FIG. 37D. The inner structure of the vertebra segment 952of FIG. 37E has an instrument channel 960, as well as channels for theupper needle pair 964, lower needle pair 956, the upper suture passage968, lower suture passage 972, and the upper steering cables 962, 966for the distal tip.

FIG. 37F is a cross-section of the vertebra link segment of FIG. 36. Theinner structure is similar to the vertebra segment of 952 FIG. 37E, butthe vertebra segment 954 illustrated in FIG. 37F has two recesses 980,982 that terminate and are configured to hold the lower distal tipsteering cable couplers. The inner structure of the vertebra segment 954of FIG. 37F has an instrument channel 960, as well as channels for theupper needle pair 964, lower needle pair 956, the upper suture passage968, the lower suture passage 972, and upper steering cables 962, 966.

FIGS. 38A and 38B are perspective views of the unique vertebra segmentof FIG. 37A. The features regarding the internal structure of thisvertebra segment 944 have been described in detail with regard to FIG.37A. The vertebra segment illustrated in FIGS. 38A and 38B furtherdefines a vertebra recess 986 configured to link similar or distinctvertebra segments as described herein, depending the desired length ofchain or inner channel configuration of a particular embodiment. Thevertebra segment 944 also defines a recessed portion 984 about itscircumference on the proximal end 944P such that the vertebra segmentend can be inserted into the hollow end of the rigid shaft componentduring assembly of this embodiment. FIGS. 39A-39F are front, left side,right side, rear, top, and bottom elevational views, respectively of theunique vertebra segment of FIGS. 38A-38B.

FIGS. 40A and 40B are perspective views of the unique vertebra segmentof FIG. 37B. The features regarding the internal structure of thisvertebra segment 946 have been described in detail with regard to FIG.37B. The vertebra segment 946 also defines a link 994 on the proximalend 946P and a recess 992 on the distal end 946D that are configured tointerlock with a corresponding recess or link of a subsequent vertebrasegment in the flexible shaft. FIGS. 41A-41F are front, left side, rightside, rear, top, and bottom elevational views, respectively of theunique vertebra segment of FIGS. 40A-40B.

FIGS. 42A and 42B are perspective views of the unique vertebra segmentof FIG. 37C. The features regarding the internal structure of thisvertebra segment 948 have been described in detail with regard to FIG.37C. The vertebra segment also defines a link 1000 on the proximal end948P and a recess 998 on the distal end 948P that are configured tointerlock with a corresponding recess or link of a subsequent vertebrasegment in the flexible shaft. FIGS. 43A-43F are front, left side, rightside, rear, top, and bottom elevational views, respectively of theunique vertebra segment of FIGS. 42A-42B.

FIGS. 44A and 44B are perspective views of the unique vertebra segmentof FIG. 37D. The features regarding the internal structure of thisvertebra segment 950 have been described in detail with regard to FIG.37D. The vertebra segment also defines a link 1000 on the proximal end950P and a recess 1004 on the distal end 950D that are configured tointerlock with a corresponding recess or link of a subsequent vertebrasegment in the flexible shaft. A recess 976 for a lower flexible shaftsteering coupler is also visible in this view. FIGS. 45A-45F are front,left side, right side, rear, top, and bottom elevational views,respectively of the unique vertebra segment of FIGS. 44A and 44B.

FIGS. 46A and 46B are perspective views of the unique vertebra segmentof FIG. 37E. The features regarding the internal structure of thisvertebra segment 952 have been described in detail with regard to FIG.37E. The vertebra segment 952 defines a link 1012 on the proximal end952P and a link 1010 on the distal end 952D that are configured tointerlock with a corresponding recess of a previous or subsequentvertebra segment in the flexible shaft. FIGS. 47A-47F are front, leftside, right side, rear, top, and bottom elevational views, respectivelyof the unique vertebra segment of FIGS. 46A and 46B.

FIGS. 48A and 48B are perspective views of the unique vertebra segmentof FIG. 37F. The features regarding the internal structure of thisvertebra segment 954 have been described in detail with regard to FIG.37F. The vertebra segment 954 defines a recess 1016 on the proximal end954P and a post 1014 on the distal end 954D. The recess 1016 isconfigured to interlock with a corresponding link of a previous vertebrasegment in the flexible shaft. The post 1014 is configured to beinserted into the central channel of the distal tip. FIGS. 49A-49F arefront, left side, right side, rear, top, and bottom elevational views,respectively of the unique vertebra segment of FIGS. 48A and 48B.

FIG. 50 is a perspective view of another embodiment of a surgicalsuturing device as described herein. This embodiment of a surgicalsuturing device 1018 has a housing 1024 which defines a handle 1026, alever stop 1038, a grip 1036, a telescope housing 1020, and a slot 1042on the top surface of the housing 1024. The top of the lever stop 1038may have internal gear stops (not shown in this view) to engage acorresponding tab on a distal tip articulation lever 1030. The housing1024 further defines a slot 1040 within the lever stop that allowsmovement of the distal tip articulation lever 1030 towards a distal end1018D or a proximal end 1018P of the surgical suturing device 1018. Thedistal tip articulation lever 1030 also is configured such that it canflex in a direction away from the gear stops and can be moved to adesired position and released, where the lever 1030 is biased such thata key on the articulation lever 1030 engages with the appropriate gearstop, preventing undesired movement of the articulation lever 1030. Thisdescribed mechanism may also include positional keyways as described inregard to previous embodiments. The distal tip articulation lever 1030adjusts the position of the flexible portion 1046 of the shaft andtherefore the position of the distal tip 1048. This distal tiparticulation lever 1030 may also be referred to as a distal tip steeringactuator. The top of the housing 1024 further defines two slots 1042that allows movement of a first needle driver 1032 or needle actuatorand a second needle driver 1034 or needle actuator towards either thedistal end 1018D or the proximal end 1018P of the surgical suturingdevice 1018. Towards the proximal end 1018P of the surgical suturingdevice 1018, a rigid shaft portion 1044 is attached to a mount heldcaptive in the housing 1024. Further towards the proximal end 1018P ofthe surgical suturing device 1018, a flexible shaft portion 1046 isattached to the rigid shaft 1044, terminating in a distal tip 1048. Thedistal tip 1048 defines a first tissue gap and a second tissue gap,which in this embodiment are symmetrical and facing opposite directions.This distal tip 1048 embodiment is further described later. Whilediscussed later with regard to the linkage exploded views, the needlepassages in the middle link in the flexible shaft portion 1046 are notenclosed and configured such that the needle tubes can flexapproximately 30 degrees. In this embodiment, the needles and thesutures are passed through plastic or suture tubes held within thesuture passages and needle channels. Other embodiments may not utilizesuture tubes, but may have alternate path or channel materials for thevarious cables, sutures, and needles to pass through the variouselements of the instrument shaft, including the rigid shaft section andthe flexible shaft section.

FIG. 51A and FIG. 51B are perspective views of the distal tip of thesurgical suturing device of FIG. 50. The distal tip 1048 has a tip body1050 which defines an instrument channel 1060 along one side of the tipbody. This instrument channel 1060 is configured to releasably holdvarious instrumentation used in a minimally invasive surgical procedurefor treatment of tricuspid regurgitation. The instrument channel 1060 inthe distal tip 1048 is also in communication with the instrument channelthat is formed by the various segments of the flexible shaft portion, aspreviously described. This channel continues back to the proximal end ofthe surgical suturing instrument. An example of an instrument used inthis instance is an intracardiac echocardiography (ICE) probe which isuseful in aiding visualization of various surgical procedure steps inthe treatment of tricuspid regurgitation. Other instrumentation may alsobe configured for use within the instrument channel for visualization,tissue grasping, or other uses within a minimally invasive surgicalprocedure. A flexible grasper may be useful in bringing tissue in closerproximity to either of an upper tissue bite area 1056 or a lower tissuebite area 1058 of the distal tip. The tip body 1050 further defines fourupper needle channels 1062 and four lower needle channels 1062configured to guide two sets of flexible needles across the upper tissuebite area 1056 and across the lower tissue bite area 1058 to engage andpick up their corresponding ferrules and therefore the attached sutureends in the surgical suturing device. Towards the distal end of thedistal tip 1048 is a tip support 1052 or strut that defines an uppertissue bite area 1056 and a lower tissue bite area 1058. At the distalend of the tip support 1052, there is a tip head 1054 that defines foursuture passages 1064, eight suture guides 1066, and eight ferruleholders 1072 for organizing and holding suture and ferrules in thedistal tip and along the shaft. The suture passages 1064 are incommunication and tunnel through from the distal tip head 1054 to thetip support 1052, further through the distal tip body 1050 and throughthe shaft and back to the handle in the surgical suturing instrument.The suture may alternately follow an internal path through variouschannels within the distal tip 1048 or be closely held in contact withthe via suture holding features or guides along the distal tip 1048.This distal tip 1048 may have differing numbers of suture passages 1064,suture guides 1066, and ferrule holders 1072 depending on the details ofthe minimally invasive surgical procedure in which the instrument may beemployed. FIGS. 52A, 52B, 52C, 52D, 52E, and 52F are front, left side,right side, rear, top, and bottom elevational views, respectively, ofthe distal tip shown in FIGS. 51A and 51B. FIG. 53 illustrates aleft-front perspective view of the distal tip shown in FIGS. 51A and 51Bin the context of the instrument, with multiple needles beginning tospan the tissue bite area.

FIG. 54 is a perspective view of a mechanical fastener knotting devicehaving two shafts or barrels. The mechanical fastener knotting device1076 has a housing 1078 which defines a handle 1080. The mechanicalfastener knotting device 1076 also has an actuation lever 1082.Connected to a distal end 1076D of the housing are two shafts 1084, eachhaving several support rings 1086 and each terminating in a knotting tip1088. When the lever 1082 is squeezed in a direction towards the handle1080, both knotting tips 1088 are simultaneously triggered, which willcrimp a mechanical fastener loaded into each knotting tip 1088 and trimor cut any sutures or threads passed through the mechanical fasteners.Suitable mechanical fastening devices, such as, but not limited to, theCOR-KNOT® fastening device from LSI Solutions, Inc. (Victor, N.Y.) areintended for use in such a mechanical fastener knotting device. Anadvantage of a double-barrel mechanical fastener knotting device 1076such as the one illustrated in FIG. 54 could be to reduce procedure timefor a minimally invasive surgical procedure such as the tricuspidannular plication procedures described herein, by reducing the timerequired to fasten or stitch sutures in separate procedural steps. Forexample, one actuation of this device could effectively apply mechanicalfasteners to four suture ends at once, which could be advantageous forthe procedure described herein, as well as others requiring multiplefasteners.

FIGS. 55A and 55B are top and bottom perspective views, respectively, ofa cannula for use in combination with the surgical suturing device ofFIG. 50. The cannula 1090 may be provided for intercostal access to theright atrium of the heart while the heart is beating, such as in theprocedure described previously in regard to FIGS. 4A-4R. On a proximalend 1090P, the cannula 1090 has an organization template 1092 around thecircumference of the cannula. The organization template 1092 has tubemanagement grooves 1093 around a portion of the circumference in whichone or more tubes from a suture placement device may be mounted. Asection of the organization template 1092 is devoid of tube managementgrooves 1093, and this corresponds to a portion of the tricuspid valvewhich should not be sutured, so that needles do not pierce vitalsegments of the heart's conduction path. This visual reminder on theorganization template 1092 is a helpful reminder for surgeons. Thecannula 1090 has a riser tube 1094 which is sized to allow the cannula1090 to reach an incision in the right atrium, but is long enough sothat the slightly pressurized blood passing through the right atriumduring this beating heart procedure does not rise above and out of thecannula 1090. The distal end 1090D of the cannula 1090 has a groove 1096to which a pursestring suture placed into the heart at the incisionpoint may be tied to secure the heart tissue to the cannula 1090.Looking at the underside of the proximal end 1090P of the cannula 1090,it can be seen that there are suture pinching slots 1098 for holdingvarious sutures if desired. The cannula can have an optional adapter,not shown here, for coupling to a stabilization arm or surgicalequipment holder.

FIG. 56 is a top view of the flexible shaft portion of the surgicalsuturing device of FIG. 50, detailing a number of unique vertebraesegments or links, the cross-sections of which are shown in greaterdetail in FIGS. 57A-57C. These vertebrae segments 1100, 1102, 1104, whenconnected, comprise the flexible shaft 1046 of the surgical suturingdevice of FIG. 50. Illustrated in FIG. 56 is a first vertebrae 1100indicated by cross-sectional marker 57A, an articulating vertebraesegment 1102 indicated by cross-sectional marker 57B, and a distalvertebra segment 1104 indicated by cross-sectional marker 57C. The firstvertebrae 1100, indicated by cross-sectional marker 57A, includes alinking end to fixedly attach the flexible shaft to the rigid shaft ofthe surgical suturing device. The cross-sectional features of thesevertebrae are further discussed in regard to FIGS. 57A, 57B, and 57C.The cross-sectional features shown in this embodiment of the surgicalsuturing device are one arrangement, and it should be noted that otherarrangements or configurations may be useful or effective in maintainingand articulating the various control and steering cables, sutures, guidewire, and flexible needle pairs or sets along the internal path of aflexible shaft may be known to those skilled in the art.

FIG. 57A is a cross-section of the indicated vertebra segment of FIG.56. The inner structure of the first vertebra 1100 possesses severalfeatures related to pathway management throughout the length of theflexible shaft. The vertebra segment 1100 defines four upper needlechannels 1112 and four lower needle channels 1112 which are configuredto guide the first needle set and second needle set, respectively, alongthe flexible shaft. The vertebra segment also defines a central suturepassage 1106, as well as channels 1110 for the distal tip steeringcables.

FIG. 57B represents a link or vertebra segment. FIG. 57B is across-section of the vertebra segment indicated in FIG. 56. The innerstructure of this vertebra 1102 possesses several features related tocable pathway management throughout the length of the flexible shaft.The inner structure is similar to the inner structure of the vertebraillustrated in FIG. 57A, however, the needle passages 1112 in thevertebra segment of FIG. 57B are deeper, allowing some flexure of theneedles or the tubes within which the needles travel through thesurgical suturing device. The inner structure of the vertebra segment ofFIG. 57B also has a suture passage 1106, configured to hold suturesenclosed within plastic tubes, as well as channels 1110 for the distaltip steering cables for the flexible shaft.

FIG. 57C is a cross section of the indicated vertebra segment of FIG.57C. The inner structure of this vertebra possesses several featuresrelated to cable pathway management throughout the length of theflexible shaft. The inner structure is similar to the vertebrae 1100,1102 illustrated in FIGS. 57A-57B, but the vertebra segment 1104illustrated in FIG. 57C has an instrument channel 1114 configured tohold an instrument such as an ICE probe near the distal tip of thesurgical suturing device for improved visualization during a minimallyinvasive surgical procedure such as a tricuspid annular plication. Theinner structure of the vertebra segment 1104 of FIG. 57C also defineschannels for the upper needle set 1112, lower needle set 1112, andsuture passage 1106.

FIGS. 58A and 58B are perspective views of the unique vertebra segmentof FIG. 57A. The features regarding the internal structure of thisvertebra segment have been described in detail with regard to FIG. 57A.The vertebra segment also defines a recessed portion 1116 about itscircumference on the proximal end 1100P such that the vertebra segmentend can be inserted into the hollow end of the rigid shaft componentduring assembly of this embodiment. The vertebra segment 1100 alsodefines a recess 1118 on the distal end 1100D that is configured tointerlock with a link of a subsequent vertebra segment in the flexibleshaft. FIGS. 59A-59F are front, left side, right side, rear, top, andbottom elevational views, respectively of the unique vertebra segment ofFIGS. 58A-58B.

FIGS. 60A and 60B are perspective views of the unique vertebra segment1102 of FIG. 58B. The features regarding the internal structure of thisproximal link vertebra segment have been described in detail with regardto FIG. 58B. The vertebra segment 1102 defines a link 1120 on theproximal end 1102P and a link 1122 on the distal end 1102D that areconfigured to interlock with a corresponding recess of a previous orsubsequent vertebra segment in the flexible shaft. FIGS. 61A-61F arefront, left side, right side, rear, top, and bottom elevational views,respectively of the unique vertebra segment of FIGS. 60A and 60B.

FIGS. 62A and 62B are perspective views of the unique vertebra segmentof FIG. 58C. The features regarding the internal structure of this linkvertebra segment have been described in detail with regard to FIG. 58C.The vertebra segment 1104 defines a recess 1124 on the proximal end1104P and a post 1126 on the distal end 1104D. The recess 1124 isconfigured to interlock with a corresponding link of a previous vertebrasegment in the flexible shaft. The post 1126 is configured to beinserted into the distal tip 1048 illustrated in FIGS. 51A-51B. FIGS.63A-63F are front, left side, right side, rear, top, and bottomelevational views, respectively of the unique vertebra segment of FIGS.62A and 62B.

FIG. 64 is a perspective view of another embodiment of a surgicalsuturing device as described herein. This embodiment of a surgicalsuturing device 1128 has a housing 1130 which defines a handle 1132further defining a grip 1134, a telescope handle 1136, and several slots1142 on the top surface of the housing 1130. The slots 1142 in thehousing 1130 accommodate a first needle drive lever 1138 and a secondneedle drive lever 1140. The housing 1130 of the surgical suturingdevice 1128 also defines a suture storage and viewing window 1144.Connected to the housing 1130 is a shaft 1146 which terminates in adistal tip 1148 which further defines a first upper tissue bite area1150 and a second lower tissue bite area 1152. The purpose and functionof most of the salient features of this embodiment of a surgicalsuturing device 1128 have been described previously, and those whichhave not will be further discussed.

FIG. 65 is a perspective view of an embodiment of a mechanical fastenerknotting device having three shafts or barrels. The mechanical fastenerknotting device 1154 has a housing 1160 which defines a handle 1162. Themechanical fastener knotting device 1154 also has an actuation lever1164. Connected to a distal end 1154D of the housing are three shafts1166, with at least one support ring 1170 and with each shaftterminating in a knotting tip 1172. When the lever 1164 is squeezed in adirection towards the handle 1162, all three knotting tips 1172 aresimultaneously triggered, which will crimp a mechanical fastener loadedinto each knotting tip 1172 and trim or cut any sutures or threadspassed through the mechanical fasteners. One actuation of the lever willeffectively fasten three mechanical fasteners. Similar suitablemechanical fastening devices, such as, but not limited to, the COR-KNOT®fastening device from LSI Solutions, Inc. (Victor, N.Y.) are intendedfor use in such a mechanical fastener knotting device. An advantage of atriple-barrel mechanical fastener knotting device 1154 such as the oneillustrated in FIG. 66 is to reduce procedure time for a minimallyinvasive surgical procedure such as the tricuspid annular plicationprocedures described herein, by reducing the time required to fasten orstitch sutures as compared to fastening using separate procedural stepsor instruments for each fastener. For example, one actuation of thisdevice could effectively apply mechanical fasteners to six suture endsat once, which could be advantageous for the procedure described hereinas well as other procedures requiring multiple sutures or fasteners.This knotting device 1154 also has a sealing collar 1168 to maintain aseal within cannula when inserting the knotting device into a minimallyinvasive surgical site. This sealing collar 1168 may be constructed of aplastic, metal, or elastomeric material depending on the maneuverabilityrequired for the knotting device 1154 when inserted into a cannula orport when reaching a surgical site.

FIG. 66A is a perspective view of an alternate embodiment of a distaltip for the surgical suturing device of FIG. 64. The distal tip for thisembodiment would accommodate twelve needles in two pairs of six, alongwith six suture pairs for use in a minimally invasive surgical proceduresimilar to the one described in regard to FIGS. 4A-4R, but with sixsuture pains other than two. The distal tip 1148 has a tip body 1212which defines an internal instrument channel 1214 via the center of thetip body 1212. This instrument channel 1214 is configured to releasablyhold various instrumentation used in a minimally invasive surgicalprocedure for treatment of tricuspid regurgitation. The distal tip 1148also accommodates instrumentation in the instrument channel 1214 withoutcompromising the depth of the tissue bite. The instrument channel 1214in the distal tip 1148 is also in communication with the instrumentchannel that is formed by the various segments of the shaft. Thischannel continues back to the proximal end of the surgical suturinginstrument where an instrument such as an intracardiac echocardiography(ICE) probe, which is not shown in this view, may be inserted. Otherinstrumentation may also be configured for use within the instrumentchannel for visualization, tissue grasping, or other uses within aminimally invasive surgical procedure. A flexible grasper may be usefulin bringing tissue in closer proximity to either of the upper tissuebite area or the lower tissue bite area of the distal tip. The tip body1212 further defines six upper needle channels 1218 and six lower needlechannels (not visible here) configured to guide the two sets of flexibleneedles across an upper tissue bite area 1150 and across a lower tissuebite area 1152, that are both defined by the distal tip 1148, to engageand pick up their corresponding ferrules and therefore the attachedsuture ends in the surgical suturing device. Towards the distal end ofthe distal tip is a tip support 1226 or strut that defines the uppertissue bite area 1150 and lower tissue bite area 1152. The tip support1226 also defines a viewing port 1216, which allows visibility into boththe upper tissue bite area 1150 and the lower tissue bite area 1152 viathe instrument channel 1214. At the distal end of the tip support 1226,there is a tip head 1224 that defines six suture passages 1220, twelvesuture guides 1222, and twelve ferrule holders 1228 for organizing andholding suture and ferrules in the distal tip and along the shaft. Theferrule holders 1228 are aligned with the needle channels 1218. Thesuture passages 1220 are in communication with and tunnel through fromthe distal tip head 1224 to the tip support 1226, further through thedistal tip body 1212, through the shaft, and back to the handle of thesurgical suturing instrument. The suture may alternately follow aninternal path through various channels within the distal tip or beclosely held in contact with suture holding features or guides along thedistal tip. Alternate embodiments of this distal tip may have differingnumbers of suture passages, suture guides, and ferrule holders dependingon the number of needles or on the details of the minimally invasivesurgical procedure in which the instrument may be employed. For example,this tip is arranged to have six lower needles and six upper needlesthat are driven in pairs by needle drive actuators similar to thosedescribed in regard to previous embodiments. It should be noted that theneedles in any of the embodiments described herein could be articulatedindividually, or in alternatively arranged pairs or coordinated sets orpluralities. Increasing the number of needle pairs or sets from two tofour and subsequently to six or more provides the advantage for theoperator of having the ability to introduce more sutures per bite, thusreducing the operating procedural time and improving the efficiency andefficacy of the operational procedure. Different orientations andspacing between each needle on either the top or bottom of the distaltip may also be used to improve accuracy of suturing or to avoidanatomical features during a minimally invasive surgical procedure. Anembodiment employing such a distal tip as described in FIG. 66A may alsonecessitate enlarged or greater numbers of features of the surgicalsuturing device described herein, including but not limited to barrelsconfigured to hold more needles, a wider retracting telescope, and alarger or greater numbers of needle alignment blocks.

FIG. 66B is a front-view of the distal tip for a surgical suturingdevice of FIG. 66A. As the surgical suturing device distal tip shown inFIG. 66A is introduced into the surgical site, the suturing and needlebites to be performed must be located in the intended position. Asillustrated in FIG. 66B, the positions of the needles as indicated bythe location of the ferrule holders 1228 and suture guides 1222 shownare slightly asymmetrical as compared to the spacing and positions ofthe needles and suture guides of previous embodiments. One purpose ofthis positioning is to avoid the bundle of HIS, a collection of heartmuscle cells integral to electrical conduction in the heart, when makingthe required suture bites during a minimally invasive surgical proceduresuch as the one described herein. Other needle arrangements, spacings,or positioning may be used to either avoid or intentionally targetparticular anatomical features during a given minimally invasivesurgical procedure, and other procedures aside from the one describedherein may be accomplished with embodiments of the disclosed device. Inaddition to lateral needle spacing, needle bite depth may also beindividually configured for each needle within the distal tip bymodifying the shape and contour profile of the tip support or strut inthe distal tip, depending on the intended suturing result or theparticulars of the anatomical location of a minimally invasive surgicalprocedure for which the surgical suturing device may be used.

FIGS. 67A-67H, and 67J-67L are a series of schematic illustrations of asurgical method for repair of tricuspid regurgitation using the surgicalsuturing device of FIG. 64. Considering the surgical situationillustrated in FIGS. 4A-4R, and particularly the steps illustrated inFIGS. 4A-4L, it may be desirable for a surgeon to perform a minimallyinvasive tricuspid annular plication similar to the one described inregard to FIGS. 4A-4R by introduction of a surgical suturing device viaan intercostal pathway rather than via the inner jugular vein. Theintroduction of a surgical suturing instrument such as the one shown inFIG. 64 through a cannula such as the one described later in regard toFIGS. 55A-55B, would not necessarily require the same degrees of freedomof movement or geometrical arrangement of the rigid shaft, flexibleshaft, distal tip and needle arrangement as some of the previouslydescribed embodiments of the surgical suturing device embodimentsdescribed previously herein. An intercostal introduction of a surgicalsuturing device such as the one illustrated in FIG. 64 has a shortershaft and does not have any distal tip articulation capability withrespect to the position of the shaft and handle of the surgical suturingdevice. Such an instrument may also have a shorter retracting telescopegiven a shorter distance from the outside of the body to the rightatrium as compared to the procedure illustrated in FIGS. 4A-4R, and 5.This type of minimally invasive surgical procedure may also be doneunder guidance of visualization methods such as TEE (transesophagealechocardiogram) or ICE (intra-cardiac echocardiography). FIG. 67Aillustrates a side view of a heart 1174 with the general locations ofthe superior vena cava 1176, inferior vena cava 1178, right atrium 1180,tricuspid valve 1182, and tricuspid annulus 1184 indicated. FIG. 67Billustrates the introduction of a surgical suturing device into theright atrium 1180, with the first upper tissue bite area 1150 placed onthe tricuspid annulus 1184, exerting pressure to obtain an appropriatebite depth. Only the shaft 1146 and the distal tip 1148 of theinstrument are visible in this view.

FIG. 67C illustrates a step in the surgical sequence wherein the firstneedle driver actuator is moved in a distal direction to advance theplurality of upper needles 1186 through the first upper tissue bite area1150, through the tissue of the tricuspid annulus 1184 and into theferrules. In FIG. 67D the first needle driver is pulled proximally toretract the plurality of upper needles 1186 attached to the ferrules,which are attached to their respective sutures 1192. This concept hasbeen detailed previously herein. The retracting telescope of thesurgical suturing device is pulled back partially in order to providesome slack on the sutures and allow for subsequent distal tip placementand placement of the second lower tissue bite area 1152 within thetricuspid valve 1182. FIG. 67E illustrates the placement of the secondlower tissue bite area 1152 onto another location of the tricuspidannulus 1184, exerting pressure to obtain an appropriate bite depth.This step may be accomplished with the assistance of either directvisualization of with visualization guidance by instrumentation.

FIG. 67F The second needle driver actuator is moved in a distaldirection to advance the four upper needles through the upper tissuebite area and through the tissue and into the ferrules. FIG. 67Fillustrates a step in the surgical sequence wherein the second needledriver actuator is moved in a distal direction to advance the pluralityof lower needles 1188 through the second lower tissue bite area 1152,through the tissue of the tricuspid annulus 1184 and into its respectiveferrules. Subsequently, the second needle driver is pulled proximally toretract the plurality of lower needles 1188 attached to the ferruleswhich are attached to their respective sutures.

FIG. 67G illustrates the step in the surgical procedure where there isstill slack in the sutures 1192 and the retracting telescope handle hasbeen slowly and fully pulled away from the heart to payout suturesthrough the tissue and back through the body of the surgical suturingdevice. FIG. 67H shows a step in the surgical procedure where theoperator, while holding the retracting telescope stationary, removes thehandle and remaining portion of the surgical suturing device of FIG. 64.This leaves twelve suture ends exiting the surgical site, possibly at acannula such as the one further described in regard to FIG. 55A-55B.

FIG. 67J illustrates the use of a mechanical fastener knotting devicehaving three shafts or barrels as previously shown in and described inregard to FIG. 65 to secure the portion of the sutures 1190 attached atthe first suture site described in regard to FIG. 67C. The knotting tips1198 of a first triple knotting device 1196 are placed in proximity tothe suture sites, and the device is actuated, simultaneously applyingthree mechanical fasteners and trimming the ends of the sutures 1190.FIG. 67K illustrates the suture site having a first pledget 1204fastened to the first suturing site described in regard to FIG. 67Cusing a first set of three mechanical fasteners 1206. Also shown is theintroduction of a second triple knotting device 1200 having three shaftsor barrels as previously shown in and described in regard to FIG. 65 tosecure the portion of the sutures 1190 attached at the second suturesite described in regard to FIG. 67F. The sutures 1190 are shown in apartially loose state, yet once they are fully tightened and thetricuspid annular plication is in a state that is satisfactory to thesurgeon, the knotting tips 1202 of the second triple knotting device1200 are placed in proximity to the suture sites, the sutures are fullytightened and the device is actuated, simultaneously applying threemechanical fasteners and trimming the ends of the sutures 1190. FIG. 67Lshows the completed plication, with the mechanical fasteners 1210 fullysecuring the second suturing site with a second pledget 1208 in thetricuspid annulus 1184.

FIGS. 68A and 68B are top-left-front perspective views of internalportions of an embodiment of a surgical suturing device highlighting thearrangement of a set of needles. FIG. 68A illustrates an internalportion of a surgical suturing device, showing a second needle drivelever similar to those previously described herein. The second needledrive lever 1230 defines a barrel catch 1248 configured to hold a distalbarrel 1250 for a group of needles and a pivot hole 1246 about which thesecond needle drive lever 1230 pivots. Extending from the distal barrel1250 is a group of six needle tubes 1232, which are configured toslidably and coaxially enclose a needle within each of the needle tubes1232. The needle tubes 1232 pass through a proximal needle tube lockplate 1244 towards and through the shaft (not shown here) of a surgicalsuturing instrument through a divergent path 1234 for the tubes andneedles, through an inner shaft, to terminate in a distal needle tubelocking plate 1240. The needles (not shown in this view) exit the needletubes 1232 and are configured to be driven through the tissue bite area1238 of the distal tip 1236 when the second needle drive lever 1230 isactuated. Each tube 1232 has a notch at either end that sits within andis locked into a protrusion, with a corresponding notch and protrusionpair at the opposite end to fixedly seat the tube in the stationaryblock end. This set of features, which will be described in more detail,sets the length of tube held fixed at a constant length from the distalneedle tube lock plate 1240 to the proximal needle tube lock plate 1240.The needle tubes 1232 carrying the needles may follow different pathswithin the surgical suturing device from the distal end to the proximalend. While the paths differ, the distance of needle travel will be thesame independent of the path they take through the instrument as aresult of this notch protrusion pair feature at either end. This set offeatures guarantees the needles will be the same length and be driventhe same distance when actuated. If no notch and protrusion feature setor method of setting length via tube was utilized, it could require 6different lengths of needles and/or tubes in a set to insure consistentneedle lengths and needle drive distances. Other means of achieving aconsistent length needle may be known in the art and may be used inalternate embodiments. In addition to these needle tube lock plates,alternate needle supports may also be used to guide needle tube andneedle pathways from the distal end to the proximal end of the surgicalsuturing device.

FIG. 68B is a top-left-front perspective view of the internal portion ofthe surgical suturing device of FIG. 68A, showing the second needledrive lever similar to those previously described herein being actuatedto drive the upper needle set forward. As the second needle drive lever1230 is actuated in a forward direction 1254, the needles slide withinthe needle tubes 1232 and advance forward to traverse the tissue bitearea 1238 in the distal tip 1236. All needles travel the same distanceforward to pick up their respective ferrules (not shown here), and theneedle tubes 1232 remain stationary.

FIG. 69 is a top-left-front perspective view of internal portions of theembodiment of the surgical suturing device of FIGS. 68A and 68B furtherhighlighting the arrangement of a set of needles. FIG. 69 illustratesthe details of how an embodiment of a surgical suturing device holds theneedle tubes within the distal tip in the distal needle lock plate. Thedistal needle lock plate 1240 defines several protrusions 1260 that areeach configured to mate with a corresponding tube notch 1258 in eachneedle tube 1232. The size and depth of the notch 1258 in the needletube 1232 does not prohibit or restrict the needle from traveling withinthe tube but is substantial enough to restrict movement of the needletube once it is placed in the distal needle tube lock plate.

FIG. 70 is a cross-sectional side view of a segment of the internalportions of a surgical suturing device shown in FIG. 69. FIG. 70illustrates the details of how an embodiment of a surgical suturingdevice holds the needle tubes 1262 in the housing within the proximalneedle lock plate 1240. The proximal needle lock plate 1240 defines aprotrusion 1260 for each needle tube 1262 configured to mate with acorresponding tube notch 1258 in each needle tube 1262 at the proximalend 1262P of the needle tube 1262. The size and depth of the notch 1258in the needle tube 1262 does not prohibit or restrict the needle 1264from traveling within the tube 1262 but is substantial enough torestrict movement of the needle tube 1262 once it is placed in theproximal needle tube lock plate 1240. Alternate embodiments forrestricting the length and holding in place needle tubes may be employedsuch as clamps, screws, or other means of mechanical restriction. Othermeans of restricting the needle tubes to a fixed distance between theproximal and distal end of a surgical suturing device may be known tothose skilled in the art, provided the needles may still pass freelywithin the needle tube once the needle tube is held in place. Inaddition to tubes, alternate embodiments may have additional structuralsupport inside the device housing or within other components for theneedles or tubes which may be used in order to better facilitate, guideor direct the management of needle pathways throughout the surgicalsuturing device. Such needle tube guides or supports may be arrangedwith alternate spacing or orientation in a manner intended to facilitateefficient operation and movement of the needles within the needle tubes.Alternatively, the shape and orientation of one of the needle lockplates may be configured or oriented in other patterns or arrangementsto control the position of the needle tubes.

FIG. 71 is a top-right-front perspective view of another embodiment of adistal tip for a surgical suturing device. The distal tip 1266 shown inFIG. 71 is similar to other embodiments shown herein, but has a singletissue gap 1286, rather than two tissue gaps on opposing sides of thedistal tip. Most of the features of this embodiment of a distal tip 1266share a common purpose to corresponding features in other embodimentsdescribed previously. The distal tip 1266 is characterized by a tip body1268, a tip support 1270 connected to the tip body 1268, and a tip head1272 towards the distal end 1266D of the distal tip 1266 connected tothe tip support 1270. The distal tip 1266 also defines a set of upperneedle channels 1274 and a set of lower needle channels 1276. The tipsupport 1270 defines a viewing port 1278 configured such that aninstrument held within an instrument channel, which is included in thisembodiment but is not visible, could have visual access to a suturingsite during a minimally invasive surgical procedure. The tip head 1272also defines several features previously discussed herein, severalsuture guides 1280, suture channels 1284, and ferrule holders 1282.

Various advantages of a surgical suturing device for repair of tricuspidregurgitation, a loading and retrieval apparatus, and methods thereofhave been discussed above. Embodiments discussed herein have beendescribed by way of example in this specification. It will be apparentto those skilled in the art that the forgoing detailed disclosure isintended to be presented by way of example only, and is not limiting.Various alterations, improvements, and modifications will occur and areintended to those skilled in the art, though not expressly statedherein. These alterations, improvements, and modifications are intendedto be suggested hereby, and are within the spirit and the scope of theclaimed invention. Additionally, the recited order of processingelements or sequences, or the use of numbers, letters, or otherdesignations therefore, is not intended to limit the claims to anyorder, except as may be specified in the claims. Accordingly, theinvention is limited only by the following claims and equivalentsthereto.

What is claimed is:
 1. A surgical suturing device, comprising: a firsttissue gap; a second tissue gap; a first pair of needles configured tobe movable across the first tissue gap; a second pair of needlesconfigured to be movable across the second tissue gap; and a firstsuture having first and second ends; a second suture having first andsecond ends; a first ferrule coupled to the first end of the firstsuture; a second ferrule coupled to the second end of the first suture;a third ferrule coupled to the first end of the second suture; a fourthferrule coupled to the second end of the second suture; a distal tipwhich defines: the first and second tissue gaps; a first ferrule holderin which the first ferrule is installed; a second ferrule holder inwhich the second ferrule is installed; a third ferrule holder in whichthe third ferrule is installed; and a fourth ferrule holder in which thefourth ferrule is installed, wherein: the first ferrule holder and thethird ferrule holder are configured to align the first ferrule and thethird ferrule in alignment with a travel path of the first pair ofneedles when traversing the first tissue gap, respectively; and thesecond ferrule holder and the fourth ferrule holder are configured toalign the second ferrule and the fourth ferrule in alignment with atravel path of the second pair of needles when traversing the secondtissue gap, respectively; and a needle actuator which selectivelyengages either: the first pair of needles to drive them through thefirst tissue gap and into communication with the first end of the firstsuture and the first end of the second suture, respectively; or thesecond pair of needles to drive them through the second tissue gap andinto communication with the second end of the first suture and thesecond end of the second suture, respectively.
 2. The surgical suturingdevice of claim 1, wherein: the distal tip further defines one or moresuture passages through which at least a portion of the first and secondsutures are passed.
 3. The surgical suturing device of claim 1, furthercomprising a flexible shaft that is at least partially steerable.
 4. Thesurgical suturing device of claim 3, wherein the flexible shaftcomprises one or more articulating links.
 5. The surgical suturingdevice of claim 1, wherein the first tissue gap and the second tissuegap are symmetrical.
 6. The surgical suturing device of claim 1, whereinthe first tissue gap and the second tissue gap are facing oppositedirections, but offset from each other.
 7. The surgical suturing deviceof claim 3, wherein the flexible shaft comprises one or more vertebrae.8. The surgical suturing device of claim 4, further comprising aguidewire tip.
 9. The surgical suturing device of claim 8, wherein: theone or more articulating links are positioned within the guidewire tipin a retracted position; and the one or more articulating links may bearticulated to an advanced position outside of the guidewire tip.
 10. Asurgical suturing device, comprising: a first tissue gap; a secondtissue gap; a first pair of needles configured to be movable across thefirst tissue gap; a second pair of needles configured to be movableacross the second tissue gap; and a first suture having first and secondends; a second suture having first and second ends; and a flexible shaftcomprising one or more articulating links; a guidewire tip, wherein: theone or more articulating links are positioned within the guidewire tipin a retracted position; and the one or more articulating links may bearticulated to an advanced position outside of the guidewire tip; and aneedle actuator which selectively engages either: the first pair ofneedles to drive them through the first tissue gap and intocommunication with the first end of the first suture and the first endof the second suture, respectively; or the second pair of needles todrive them through the second tissue gap and into communication with thesecond end of the first suture and the second end of the second suture,respectively.
 11. The surgical suturing device of claim 10, wherein theflexible shaft is at least partially steerable.
 12. The surgicalsuturing device of claim 10, wherein the first tissue gap and the secondtissue gap are facing opposite directions, but offset from each other.13. The surgical suturing device of claim 10, wherein the first tissuegap and the second tissue gap are symmetrical.
 14. The surgical suturingdevice of claim 10, further comprising: a first ferrule coupled to thefirst end of the first suture; a second ferrule coupled to the secondend of the first suture; a third ferrule coupled to the first end of thesecond suture; and a fourth ferrule coupled to the second end of thesecond suture.
 15. The surgical suturing device of claim 14, furthercomprising a distal tip which defines: the first and second tissue gaps;a first ferrule holder in which the first ferrule is installed; a secondferrule holder in which the second ferrule is installed; a third ferruleholder in which the third ferrule is installed; and a fourth ferruleholder in which the fourth ferrule is installed.
 16. The surgicalsuturing device of claim 15, wherein: the first ferrule holder and thethird ferrule holder are configured to align the first ferrule and thethird ferrule in alignment with a travel path of the first pair ofneedles when traversing the first tissue gap, respectively; and thesecond ferrule holder and the fourth ferrule holder are configured toalign the second ferrule and the fourth ferrule in alignment with atravel path of the second pair of needles when traversing the secondtissue gap, respectively.
 17. The surgical suturing device of claim 15,wherein: the distal tip further defines one or more suture passagesthrough which at least a portion of the first and second sutures arepassed.
 18. The surgical suturing device of claim 10, wherein the needleactuator comprises: a lever; and a selection switch configured toselectively couple the lever to either the first pair of needles or thesecond pair of needles, such that when the lever is moved, the selectedfirst or second pair of needles moves through the first tissue gap orthe second tissue gap, respectively.
 19. The surgical suturing device ofclaim 10, wherein the flexible shaft comprises one or more vertebrae.